Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010-2011)

M ala ria R ap id D iag no st ic Te st Pe rfo rm an ce Re su lts o f W HO p ro du ct te st in g of m ala ria R DT s: Ro un d 3 (2 01 0- 20 11 ) Malaria Rapid Diagnostic Test Performance Results of WHO product testing of malaria RDTs: Round 3 (2010-2011)

Malaria Rapid Diagnostic Test Performance Results of WHO product testing of malaria RDTs: Round 3 (2010-2011) WHO Library Cataloguing-in-Publication Data : Malaria rapid diagnostic test performance results of WHO product testing of malaria RDTs: round 3 (2010-2011). 1.Malaria - diagnosis. 2.Antimalarials - therapeutic use. 3.Malaria - drug therapy. 4.Diagnostic tests, Routine. 5.Reagent kits, Diagnostic - utilization.. 6.Sensitivity and specificity. I.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. II.Centers for Disease Control (U.S.). III.Foundation for Innovative New Diagnostics. ISBN 978 92 4 150256 6 (NLM classification: WC 750) Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2011 All rights reserved. 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WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product. Layout: Bruno Duret Printed in Malta Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) I I I Co nt en ts acknoWledgeMents ViiiabbreViations X 1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1-3 1 1.1. introduction 1 1.2. the WHo product testing programme 1 1.3. results of the evaluation 2 1.4. summary of outcomes 3 1.5. Use of these results 3 2. WHo Malaria rdt prodUct testing: roUnd 3 eXecUtiVe sUMMarY 13 2.1. introduction 13 2.2. the WHo product testing programme 13 2.3. results of the evaluation 13 2.4. Use of these results 14 3. backgroUnd 15 4. objectiVe 16 5. Materials and MetHods 17 5.1. test selection 17 5.2. outline of the product testing protocol 17 5.3. evaluation panels 19 5.4. rdt registration 20 5.5. specimen panel registration 20 5.6. test phases 20 5.7. performing rapid tests 20 5.8. interpretation of results 20 6. data ManageMent 21 7. QUalitY assUrance 22 8. etHical considerations 22 9. data analYsis 23 9.1. Measures of parasite detection: panel detection score and positivity rates 23 9.2. false-positive results 23 9.2.1. incorrect species identification 23 9.2.2. false-positives from plasmodium-negative samples 23 9.3. band intensity 23 9.4. lot agreement 23 9.5. invalid tests 23 9.6. Heat (thermal) stability 24 10. laboratorY VersUs field-based Malaria rdt eValUations 24 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)IV 11. resUlts 25 11.1. summary 25 11.2. phase 1 - p. falciparum culture panel 30 11.3. phase 2 - Wild-type p. falciparum and p. vivax and plasmodium spp. negative samples 31 11.3.1. p. falciparum detection 31 11.3.2. p. vivax detection 32 11.3.3. combined detection of p. falciparum and p. vivax 33 11.3.4. p. falciparum and p. vivax positivity rate 33 11.3.5. band intensity 34 11.3.6. false-positive rates 35 12. Heat stabilitY 37 12.1. p. falciparum test lines 40 12.2. pan-specific test lines 43 13. ease of Use description 45 14. discUssion of keY findings 49 14.1. panel detection score (pds) and its relationship to sensitivity 49 14.2. false-positive rate and specificity 50 14.3. Heat (thermal) stability 50 14.4. ease of use description 51 14.5. inter-lot variability 51 14.6. target antigens and species 52 15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field 52 15.1. beyond procurement 52 15.2. lot testing 53 16. conclUsions 53 17. references 54 anneXes 55 annex 1: characteristics of rapid malaria tests in round 3 56 annex 2: Malaria rdt guide to results interpretation 58 annex 3: phase 1 results 70 annex 4: phase 2 results 74 annex 5a: selection of an appropriate rdt 104 annex 5b: rdt format review and ease of use assessment 105 annex 6: introducing rdt-based malaria diagnosis into national programmes 106 Reference to any company or product in this report, particularly in any of the figures or tables, does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) any list of companies or products is complete and/or error free; and/or that (2) any products listed are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion in this report does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). Any lists of RDTs are not an exhaustive list of malaria RDTs. Such lists reflect those products which have been submitted for evaluation in Round 3 of the WHO Malaria RDT Product Testing Programme. The fact that certain products are not included in any list means that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme and does not indicate anything in respect of such products’ performance. WHO will not accept any liability or responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of or in connection with the procurement, distribution and use of any product whatsoever included in this report. This report may not be used by manufacturers and suppliers for commercial or promotional purposes. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) V figUres Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/µl) and clean-negative samples Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite densities (parasites/µl) and clean-negative samples Figure 1: Mode of action of antigen-detecting malaria RDTs Figure 2: Network of specimen collection, characterization and testing sites Figure 3: Malaria RDT Product Testing Overview Figure 4a: Origin of Phase 2 P. falciparum wild-type (clinical) samples Figure 4b: Origin of Phase 2 P. vivax wild-type (clinical) samples Figure 5: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 200 parasites/µl Figure 6: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 2000 parasites/µl Figure 7: Phase 1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite densities (parasites/µl) according to target antigen type (HRP2 or pLDH) Figure 8: Phase 2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µl) according to target antigen type (HRP2 or pLDH) Figure 9: Phase 2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite densities (parasites/µl) according to target antigen type (aldolase, pLDH) Figure 10: Phase 2 P. falciparum panel detection score and positivity rate at 200 parasites/µl Figure 11: Phase 2 P. vivax panel detection score and positivity rate at 200 parasites/µl Figure 12: Phase 2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samples Figure 13: Phase 2 Plasmodium spp. (pan or P. vivax test line) false-positive rate against clean-negative samples Figure 14: Phase 2 P. falciparum false-positive rate versus P. falciparum panel detection score at low (200) parasite density (parasites/µl) Figure 15: Phase 2 P. vivax false-positive rate versus P. vivax panel detection score at low (200) parasite density (parasites/µl) Figure 16: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 17: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 18: Heat stability of P. falciparum-specific test line in combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 19: Heat stability of P. falciparum specific test line in combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 20: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 21: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 22: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation Figure 23: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation. Figure A6.1: Example malaria RDT implementation budget Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)VI tables Table S1: Malaria RDT Phase 2 performance in Rounds 1-3 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000 or 5000) parasite densities (parasites/µl) and clean-negative samples Table S2: Malaria RDT Rounds 1-3 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table S3: Product resubmissions: WHO Malaria RDT Product Testing (Rounds 1-3) Table 1: Manufacturers and products accepted into Round 3 of WHO Malaria RDT Product Testing Programme Table 2: Characteristics of Plasmodium spp. negative specimens Table 3: Summary Phase 1 performance of 50 malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000) parasite densities (parasites/µl) Table 4: Summary Phase 2 performance of 50 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax samples at low (200) and high (2000) parasite densities (parasites/µl) and Plasmodium spp. negative samples Table 5: Heat stability testing results for 50 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000) parasite densities (parasites/µl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table 6: Ease of use description of 50 malaria RDTs Table A3.1: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000) parasite densities (parasites/µl) Table A3.2: Distribution of test band intensity scores (0-4) against Phase 1 P. falciparum cultured parasites at low (200) and high (2000) parasite densities (parasites/µl) Table A4.1: Lot variability in positive results against Phase 2 wild-type P. falciparum and P. vivax samples at low (200) and high (2000) parasite densities (parasites/µl) Table A4.2: Distribution of test band intensity (0-4) scores against Phase 2 wild-type P. falciparum samples at low (200) and high (2000) parasite densities (parasites/µl) Table A4.3: Distribution of Pan/Pv test band intensity (0-4) scores for Phase 2 wild-type P. vivax samples at low (200) and high (2000) parasite densities (parasites/µl) Table A4.4: Panel detection score of Phase 2 wild-type P. falciparum in low (200) and high (2000) parasite densities (parasites/µl) by continent Table A4.5: Phase 2 P. falciparum test line false-positive rates for wild-type P. vivax samples at low (200) and high (2000) parasite densities (parasites/µl) Table A4.6: Phase 2 Pan (or P. vivax) test line false-positive rate for non-Pf infection on wild-type P. falciparum samples at low (200) and high (2000) parasite densities (parasites/µl) Table A4.7: Phase 2 false-positive rate for wild-type P. falciparum test line results on all malaria-negative samples Table A4.8: Phase 2 false-positive rate for P. falciparum in samples containing specific non-malarial infectious pathogens Table A4.9: Phase 2 false-positive rate of P. falciparum in samples containing potentially cross-reacting blood immuno- logical factors Table A4.10: Phase 2 false-positive rate of pan/P. vivax test line results on all malaria-negative samples Table A4.11: Heat stability testing results for P. falciparum (or pan) test line on a P. falciparum sample at low parasite density (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation at 4°C, 35°C and 45°C Table A4.11a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at low parasite density (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation at 4°C, 35°C and 45°C Table A4.12: Heat stability testing results for P. falciparum (or pan) test line on a P. falciparum sample at high parasite density (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation at 4°C, 35°C and 45°C Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) VII Table A4.12a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at high parasite density (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation at 4°C, 35°C and 45°C Table A4.13: Heat stability testing results for P. falciparum (or pan) test line on parasite-negative samples. Positivity rate at baseline, and after 60 days incubation at 4°C , 35°C and 45°C Table A4.13a: Heat stability testing results for pan test line of combination RDTs on parasite-negative samples. Positivity rate at baseline, and after 60 days incubation at 4°C, 35°C and 45°C Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)VIII acknoWledgeMents The evaluation described in this report was a joint project of the Global Malaria Programme (GMP), the Foundation for Innovative New Diagnostics (FIND), TDR, Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO and the US Centers for Disease Control and Prevention (CDC), under the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND, the Australian Agency for International Development (AusAID), the United States Agency for International Development (USAID), the UK Department for International Development (DFID) and TDR. The project would not have been possible without the cooperation and support of the specimen collection sites, and the specimen characterization laboratories mentioned herein, and acknowledges the technical advice from many malaria diagnostic manufacturers and developers in the development of the programme. This report on Round 3 of WHO Malaria RDT Product Testing was compiled by Jane Cunningham (Special Programme for Research and Training in Tropical Diseases (TDR), Switzerland) and David Bell (Foundation for Innovative New Diagnostics (FIND), Switzerland) The Malaria RDT Evaluation Programme of WHO, TDR and FIND is grateful to all those who contributed to the conduct of the evaluation and preparation of this Round 3 report. Salim Abdullah Ifakara Health Research and Development Centre, United Republic of Tanzania Audrey Albertini Foundation for Innovative New Diagnostics (FIND), Switzerland Frederic Ariey Institut Pasteur, Cambodia John Barnwell US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America John Bligh Hospital for Tropical Diseases, United Kingdom of Great Britain and Northern Ireland David Bell Foundation for Innovative New Diagnostics (FIND), Switzerland Andrea Bosman World Health Organization/ Global Malaria Programme, Geneva, Switzerland Sandra Buisson Hospital for Tropical Diseases, United Kingdom of Great Britain and Northern Ireland Debora Casandra US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America Qin Cheng Army Malaria Institute, Australia Peter Chiodini Hospital for Tropical Diseases, United Kingdom of Great Britain and Northern Ireland Jane Cunningham TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland Linda Dantes WHO – Regional Office for the Western Pacific, The Philippines Djibrine Djalle Institut Pasteur Bangui, Central African Republic Babacar Faye Université Cheikh Anta DIOP, Senegal Nahla Gadalla Hospital for Tropical Diseases, United Kingdom of Great Britain and Northern Ireland Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru Cyrus Garay Research Institute of Tropical Medicine, The Philippines Michelle Gatton Queensland Institute of Medical Research, Australia Jeffrey Glenn US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America Iveth Gonzalez Foundation for Innovative New Diagnostics (FIND), Switzerland Sandra Incardona Foundation for Innovative New Diagnostics (FIND), Switzerland Sophie Jones US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America Cara Kosack Médecins Sans Frontières, The Netherlands Myat Phone Kyaw Department of Medical Research, Myanamar Jennifer Luchavez Research Institute of Tropical Medicine, The Philippines Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) IX Lorraine Mationg Research Institute of Tropical Medicine, The Philippines James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia Didier Menard Institut Pasteur de Madagascar, Madagascar; Institut Pasteur, Cambodia Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Colombia Sina Nhem Institut Pasteur / National Malaria Centre (CNM), Cambodia Bernhards Ogutu Kenya Medical Research Institute (KEMRI), Kenya Pamela Onyor Kenya Medical Research Institute (KEMRI), Kenya Daniel Orozco Médecins Sans Frontières, The Netherlands Wellington Oyibo University of Lagos, Nigeria Anita Pelecanos Queensland Institute of Medical Research, Australia Mark Perkins Foundation for Innovative New Diagnostics (FIND), Switzerland Roxanne Rees-Channer Consultant (FIND), Hospital for Tropical Diseases, United Kingdom of Great Britain and Northern Ireland Muth Sinuon National Malaria Centre (CNM), Cambodia Michael Valentine US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America Melissa Vega TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland Julie Vercruysse Foundation for Innovative New Diagnostics (FIND), Switzerland Kristin Wall US Centers for Disease Control and Prevention/National Center for Global Health/Division of Malaria and Parasitic Diseases, United States of America Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)X abbreViations ACT Artemisinin-based combination therapy AMI Army Malaria Institute AusAID Australian Agency for International Development CDC United States Centers for Disease Control and Prevention CLIA Clinical Laboratory Improvement Amendments DFID UK Department for Overseas Development FIND Foundation for Innovative New Diagnostics HRP2 Histidine-rich protein 2 HTD Hospital for Tropical Diseases ISO International Organization for Standardization PCR Polymerase chain reaction PDS Panel detection score pLDH Plasmodium lactate dehydrogenase Pf Plasmodium falciparum Pv Plasmodium vivax p/µL Parasites per microlitre QA Quality assurance QC Quality control QMS Quality management systems RDT Rapid diagnostic test (for the purposes of this report, this refers to immunochromatographic lateral flow devices for the detection of malaria parasite antigens) SOP Standard Operating Procedure TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO UN United Nations USA United States of America USAID United States Agency for International Development WPRO Western Pacific Regional Office WHO World Health Organization sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 1 1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1-3 1.1. introduction The World Health Organization estimates that half the world’s population are at risk of malaria, with 225 million people developing clinical malaria in 2009 (78% in Africa), and 781,000 deaths (91% in Africa, most being children). Malaria remains endemic in 106 countries, and while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly identified, resulting in over-use of anti- malarial drugs and poor disease monitoring.1 WHO recommends that malaria case management be based on parasite-based diagnosis in all cases2. The use of antigen- detecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, forming the backbone of expansion of access to malaria diagnosis as they provide parasite-based diagnosis in areas where good quality microscopy cannot be maintained. The number of RDTs available, and the scale of their use, has rapidly increased over the past few years. However, limitations of comparative field trials and the heterogeneous nature of malaria transmission and epidemiology has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implementation, and limits the ability to extrapolate results of field trials to different populations and time periods. To this end in 2006, the World Health Organization (WHO), Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched an evalua- tion programme to assess the comparative performance of commercially available malaria RDTs. This data is guiding procurement decisions and helping to drive improvement in the quality of manufacturing. The results of the first and second rounds of Product Testing were published in 2009 and 2010, and now form the basis of procurement criteria of WHO and UN agencies and national governments. This Summary presents an overview of the results of the first, second and third rounds of WHO Product Testing of malaria antigen-detecting RDTs completed in 2008, 2009 and 2011 respectively, and is published in conjunction with the release of the results of Round 3. The results of the three rounds of testing should be considered as a single data set. Concerning products re-submitted for evaluation, the results of earlier rounds are replaced by subsequent rounds and therefore only one set of results per product feature in 1 World Malaria Report 2010. Geneva, World Health Organization, 2010. 2 Guidelines for the Treatment of Malaria, Second Edition. Geneva, World Health Organization, 2010. this summary. Separate full reports of all rounds should be consulted for further detail on product performance, and on the interpretation and use of these results. 1.2. the WHo product testing programme The RDT evaluations summarized here were performed as a collaboration between WHO, TDR, FIND, the US Centers for Disease Control and Prevention (CDC) and other partners3. All companies manufacturing under ISO 13485:2003 Quality System Standard were invited to submit up to 3 tests for evaluation under the programme. In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites, while 29 products from 13 manufacturers were evaluated in Round 2. In Round 3, 50 products were evaluated from 23 manufacturers, including 23 products re-submitted from earlier rounds (Table S3). Of these 120 total products, 118 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after two months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. Of the 118 fully evaluated products, 25 have been evaluated in more than one round. Of the 95 unique products tested by the programme, 29 detect P. falciparum alone, 57 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species- specific), 8 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. Where the same products4 have been re-submitted in subsequent rounds of testing, the latter results replace results published from the earlier round. Thus, the performance of many tests in the results below differ from those published in the Round 1 and Round 2 reports. The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement decisions of WHO and other UN agencies and national governments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad imple- mentation of reliable malaria diagnosis in areas where malaria is prevalent. A fourth round of product testing began in June 2011. 3 See full reports of Rounds 1, 2 and 3 for full list of collaborating partners. 4 Working definition of a product can be found here on page 13: http:// www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/ web3_QARDTreport.pdf (accessed 8 September 2011) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)2 1.3. results of the evaluation The results (summarized in Figures S1 and S2 and Tables S1 and S2) provide comparative data on two lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/µl) and a higher parasite density (2000 or 5000 parasites/µl). The former is well below the mean parasite density found in many populations with endemic malaria, and considered close to the threshold that tests must detect to reliably identify clinical malaria in many settings.5 For the purposes of this report, the main measure of perform- ance is the ‘panel detection score (PDS)’6; the percentage of malaria samples in the panel giving a positive result by two RDTs per lot at the lower parasite density, and a single RDT per lot at the higher parasite density. Thus, it is not a measure of RDT clinical sensitivity, or positivity rate against the panel but rather a combined measure of positivity rate, along with inter-test and inter-lot consistency. The figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases, and the rate at which invalid results occurred. The clinical sensitivity of an RDT to detect malaria is highly dependent on the local conditions, including parasite density in the target population. Sensitivity of a test will therefore differ between populations with differing levels of transmission, as their different level of immunity will affect the parasite density at which they exhibit symptoms warranting a diagnostic test. Where transmission rates are low, parasite densities in people with symptoms of malaria are likely to be lower, resulting in tests having a lower sensitivity. For this reason, test perform- ance at 200 parasites/µl is particularly important. The results in this report show comparative performance between RDTs, and give an indication of which products are likely to provide higher sensitivity in the field, particularly in populations with low-density infections. In general, as countries reduce malaria prevalence and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the detection rate at 2000 parasites/µl indicates, the sensitivity of many of these products will be similar in populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, those well protected by bed nets) and must always be taken into account when interpreting RDT results. An important caveat when predicting field sensitivity from the PDS provided in this report is that the panels used in this evaluation only include parasites known to express the target antigens. While non- expression of the target antigens has not been recorded for aldolase or pLDH, it is known that parasites infecting people in some areas of South America do not express HRP27. In areas where HRP2-deleted parasites exist, HRP2-detecting 5 Parasitological Confirmation of Malaria Diagnosis. Report of a WHO technical consultation Geneva, 6–8 October 2009. Geneva, World Health Organization, 2010. ISBN 978 92 4 159941 2 6 Termed ‘Detection Rate’ in the full report of Round 1, published in 2009. See the Round 3 report for a full explanation of the panel detection score (PDS). 7 Gamboa D et al. PLoS One, 2010: 5(1): e8091 tests will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests detecting pLDH in P. falciparum parasites will be effective in diagnosing falciparum malaria. Heat stability (summarized in Table S2) is vital to maintaining sensitivity of the test in the field. As a result, for procurement, it is essential that careful consideration be given to stability results to ensure that products to be used in areas with high temperatures of transport and storage have demonstrated stability in the product testing programme. Requirements will vary between countries: for example, if tests are to be deployed in areas where temperatures rarely rise above 30°C, less emphasis may be placed on stability at high temperatures compared to other aspects of test quality. Ease of use requirements will also vary, depending on the extent of training and the work environment of the end-users. Particularly in primary health care settings, the simpler the tests, the easier it will be to avoid errors in preparation and interpretation. Detailed results of the evaluations can be found in the reports of each evaluation,8 and at www.wpro.who.int/sites/rdt. An interactive guide to assist in selecting products with performance characteristics most suitable for a particular country health programme is found on the FIND website.9 8 Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008). Geneva, World Health Organization, 2009. ISBN 978 92 4 1598071; Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009). Geneva, World Health Organization, 2010. ISBN 978 92 4 1599467 9 Malaria RDT Interactive Guide : http://www.finddiagnostics.org/ programs/malaria/find_activities/product_testing/malaria-rdt- product-testing/index.jsp (accessed 8 Sept.2011) sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 3 1.4. summary of outcomes This laboratory-based evaluation provides a comparative measure of RDT performance in a standardized way to distinguish between well and poorly performing tests to inform procurement decisions of malaria control programmes and guide UN procurement policy. Overall, an improvement was noted in the performance of products re-submitted to Round 3 (Table S3), indicating product improvement by the manufacturers. Furthermore, the proportion of tests achieving a PDS (>75%) at 200 parasites/µl is higher than that seen in previous reports. Several RDTs from the three rounds of testing demonstrated consistent detection of malaria at low parasite densities (200 parasites/µl), have low false positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both. Performance between products varied widely at low parasite density (200 parasites/µl); however, the majority of products showed a high level of detection at 2000 or 5000 parasites/µl. P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates, but some tests targeting pLDH also exhibited high detection rates. Test performance varied between lots, and widely between similar products, confirming the advisability of lot-testing post-purchase and prior to use in the field. The results underscore the need for manufacturers to have adequate reference materials for product development and lot-release. The WHO-FIND Malaria RDT Evaluation Programme, in collaboration with the CDC, offers quality standard panels to manufacturers to assist in this process. 1.5. Use of these results Accurate diagnosis is vital to good malaria case management, whether based on microscopy or RDTs. The results of this report should be used to short-list RDTs for procurement for use in cases where good microscopy is not available or appropriate. Additionally, it is imperative that procurement decisions based on these results take into consideration local conditions of malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen variation, parasite densities, climate), as well as other important considerations, including field-based ease of use assessments, and training/retraining requirements. Furthermore, in order to ensure that the high performance demonstrated by the lots evaluated in the product testing programme is maintained, it is recommended that each lot of RDTs is also tested in a standardized way prior to dispersal to the field.10 Procurement of RDTs must not occur without programmatic and infrastructure preparation for proper use, including supply chain management, training on test usage and disposal, and training on patient management in response to results. The main report provides an algorithm (Annex 5a) to assist in this decision-making process and comprehensive guidance on several aspects of procurement can be found in ‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’.11 10 The WHO-FIND Malaria RDT Evaluation Programme provides lot-testing capacity in a number of regional laboratories free of charge, and can be accessed through Malaria_rdt@who.int and info@finddiagnostics.org. 11 Good Practices for selecting and procuring rapid diagnostic tests for malaria, Geneva, World Health Organization, 2011 ISBN 9789241501125 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)4 Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/µl) and clean-negative samples a panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * indicates tests that also detect other non-P. falciparum parasites. (see Figure S2) sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 5 Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite densities (parasites/µl) and clean-negative samples a panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)6 Ta bl e S1 : M al ar ia R DT P ha se 2 p er fo rm an ce in R ou nd s 1- 3 ag ai ns t w ild t yp e (c lin ic al ) sa m pl es c on ta in in g P. f al ci pa ru m a nd P . v iv ax a t lo w ( 20 0) a nd hi gh ( 20 00 o r 50 00 ) pa ra si te d en si tie s (p ar as it es /µ l) an d cl ea n ne ga ti ve s am pl es Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or ea Fa lse p os iti ve r at es (% ) To ta l f al se p os iti ve ra te sb (% ) In va lid ra te (% ) (n =1 20 4) Ro un d 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l Cl ea n- ne ga tiv e sa m pl es Pf samples c Pv samples d Pf samples c Pv samples d Pf s am pl es Pv s am pl es Pf s am pl es Pv s am pl es Fa ls e po si tiv e no n- Pf in fe ct io ne Fa ls e po si tiv e Pf in fe ct io nf Fa ls e po si tiv e no n- Pf in fe ct io ng Fa ls e po si tiv e Pf in fe ct io nh Fa lse p os iti ve Pl as m od iu m sp p. In fe ct io ni Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st j IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 93 .9 N /A 10 0. 0 N /A N /A 40 .0 N /A 35 .7 38 .5 0. 1 3 Ad va nc ed Q ua lit y™ M al ar ia (p .f) P OC T IT P1 10 02 TC 1 In Te c Pr od uc ts , I nc . 57 .0 N /A 10 0. 0 N /A N /A 12 .5 N /A 17 .5 16 .1 0. 0 1 Ad va nt ag e P. f. M al ar ia C ar d IR 01 60 25 J. M itr a & C o. P vt . L td . 97 .5 N /A 10 0. 0 N /A N /A 1. 3 N /A 2. 5 0. 0 0. 0 1 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 85 .9 N /A 99 .0 N /A N /A 0. 0 N /A 1. 4 2. 0 0. 1 3 Ca re St ar t™ M al ar ia H RP 2 (P f) G 01 41 Ac ce ss B io , I nc . 98 .7 N /A 98 .7 N /A N /A 5. 0 N /A 7. 5 2. 4 0. 0 1 Ca re St ar t™ M al ar ia H RP 2/ pL DH P f t es t G 01 81 Ac ce ss B io , I nc . 98 .0 N /A 10 0. 0 N /A N /A 0. 6 N /A 1. 3 3. 0 0. 0 2 Cl ea rv ie w ® M al ar ia P .f. j VB 01 Vi si on B io te ch (P ty ) L td 83 .8 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 3 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 97 .0 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 1. 0 (1 98 ) 0. 3 3 di ag no st ic ks - M al ar ia (P f) Ca ss et te KM FC 60 01 SS A Di ag no st ic s & B io te ch S ys te m s 59 .0 N /A 99 .0 N /A N /A 1. 9 N /A 2. 6 (7 7) 7. 0 0. 9 2 di ag no st ic ks - M al ar ia (P f) Di ps tic k K M FD 60 07 SS A Di ag no st ic s & B io te ch S ys te m s 80 .0 N /A 99 .0 N /A N /A 2. 5 N /A 3. 8 2. 0 0. 0 2 Fi rs t R es po ns e® M al ar ia A g H RP 2 I1 3F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. 10 0. 0 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 3. 0 0. 0 1 Fi rs tS ig n™ – M al ar ia P f C ar d Te st -- U ni m ed In te rn at io na l, In c. 31 .7 N /A 86 .1 N /A N /A 12 .5 N /A 15 .0 2. 4 (1 66 ) 0. 0 1 H ex ag on M al ar ia 58 05 1 H um an G m bH 39 .2 N /A 94 .9 N /A N /A 7. 9 (7 6) N /A 2. 5 4. 2 (1 67 ) 1. 2 1 H iS en s M al ar ia A g Pf H RP 2 Ca rd H R3 02 3 H BI C o. , L td . 87 .0 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 1. 0 0. 1 2 IC T Di ag no st ic s M al ar ia P .f. j M L0 1 IC T Di ag no st ic s 86 .9 N /A 98 .0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 3 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 81 .8 N /A 10 0. 0 N /A N /A 3. 6 (1 39 ) N /A 1. 4 4. 0 (1 99 ) 0. 3 3 Im m un oq ui ck M al ar ia F al ci pa ru m 05 02 _K 25 Bi os yn ex 91 .1 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 6 0. 0 1 M al ar ia P la sm od iu m fa lc ip ar um R ap id te st D ev ic e (W ho le b lo od ) IM A- 40 2 AC ON L ab or at or ie s, In c. 92 .4 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 1 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 84 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 3 3 On e St ep M al ar ia P .F T es t ( ca ss et te )j 52 23 52 Bl ue C ro ss B io -M ed ica l ( Be ijin g) C o. , L td . 67 .7 N /A 97 .0 N /A N /A 0. 0 N /A 2. 9 1. 0 0. 2 3 On e St ep M al ar ia P .f Te st j W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 60 .6 N /A 98 .0 N /A N /A 0. 7 (1 39 ) N /A 0. 0 0. 0 0. 2 3 On Si gh t™ - M al ar ia P f T es t 51 1- 25 -D B Am ge ni x In te rn at io na l, In c. 74 .0 N /A 99 .0 N /A N /A 8. 1 N /A 2. 5 11 .0 0. 0 2 On Si te P f A g Ra pi d Te st j R0 11 4C CT K Bi ot ec h, In c. 85 .9 N /A 10 0. 0 N /A N /A 0. 7 N /A 0. 0 3. 5 0. 0 3 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 j 30 30 10 25 Or ch id B io m ed ic al S ys te m s 96 .0 N /A 99 .0 N /A N /A 0. 0 (1 38 ) N /A 1. 5 (6 8) 1. 5 0. 9 3 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 j 30 30 20 25 Or ch id B io m ed ic al S ys te m s 89 .9 N /A 98 .0 N /A N /A 0. 0 N /A 1. 4 0. 5 0. 0 3 Pa ra H IT ® - f ( De vi ce )j 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 84 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 3 Pa ra H IT ® -f (D ip st ic k) j 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 80 .8 N /A 99 .0 N /A N /A 0. 0 N /A 1. 4 2. 5 0. 0 3 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )k 05 FK 90 St an da rd D ia gn os tic s In c. 87 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 2. 0 0. 0 3 SD B IO LI N E M al ar ia A g Pf 05 FK 50 St an da rd D ia gn os tic s, In c. 97 .5 N /A 98 .7 N /A N /A 0. 0 N /A 0. 0 2. 4 0. 0 1 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 69 .7 0. 0 99 .0 62 .9 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 Ad va nt ag e M al C ar d IR 22 10 25 J. M itr a & C o. P vt . L td . 62 .0 10 0. 0 10 0. 0 10 0. 0 2. 5 0. 0 0. 0 0. 0 4. 2 0. 0 1 Bi na x N ow M al ar ia T es t IN 66 00 50 In ve rn es s M ed ic al In no va tio ns , I nc . 91 .1 10 .0 10 0. 0 85 .0 0. 3 3. 8 (7 9) 0. 0 (1 57 ) 5. 0 0. 0 0. 3 1 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 93 .9 88 .6 99 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 3. 0 (1 99 ) 0. 1 3 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I nc . 83 .8 94 .3 10 0. 0 97 .1 2. 3 1. 4 (1 39 ) 0. 0 (1 94 ) 1. 4 0. 0 0. 2 3 Ca re St ar t™ M al ar ia H RP 2/ pL DH (P f/ PA N ) C OM BO G 01 31 Ac ce ss B io , I nc . 97 .5 90 .0 10 0. 0 95 .0 0. 3 1. 3 0. 0 2. 5 3. 0 0. 0 1 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I nc . 88 .9 91 .4 10 0. 0 10 0. 0 1. 3 0. 7 6. 1 0. 0 0. 5 0. 0 3 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I nc . 86 .9 88 .6 10 0. 0 10 0. 0 1. 8 2. 1 0. 0 0. 0 2. 5 (1 99 ) 0. 1 3 sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 7 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or ea Fa lse p os iti ve r at es (% ) To ta l f al se p os iti ve ra te sb (% ) In va lid ra te (% ) (n =1 20 4) Ro un d 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l Cl ea n- ne ga tiv e sa m pl es Pf samples c Pv samples d Pf samples c Pv samples d Pf s am pl es Pv s am pl es Pf s am pl es Pv s am pl es Fa ls e po si tiv e no n- Pf in fe ct io ne Fa ls e po si tiv e Pf in fe ct io nf Fa ls e po si tiv e no n- Pf in fe ct io ng Fa ls e po si tiv e Pf in fe ct io nh Fa lse p os iti ve Pl as m od iu m sp p. In fe ct io ni Cl ea rv ie w ® M al ar ia C om bo j VB 11 Vi si on B io te ch (P ty ) L td 82 .8 5. 7 10 0. 0 91 .4 0. 0 5. 7 0. 5 5. 7 3. 5 0. 0 3 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic ej VB 20 Vi si on B io te ch (P ty ) L td 69 .7 48 .6 98 .0 94 .3 0. 0 0. 7 (1 39 ) 0. 0 1. 4 1. 0 0. 2 3 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 98 .0 51 .4 10 0. 0 97 .1 0. 0 (3 94 ) 0. 0 0. 0 0. 0 (6 9) 2. 5 0. 3 3 Fi rs t R es po ns e® M al ar ia p LD H /H RP 2 Co m bo T es tj I1 6F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. 84 .0 75 .0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2 Fi rs tS ig n™ - P ar aV ie w (P an +P f) M al ar ia T es t 21 01 C B- 25 U ni m ed In te rn at io na l I nc . 85 .0 80 .0 99 .0 10 0. 0 0. 0 0. 6 (1 59 ) 0. 5 (1 99 ) 0. 0 25 .5 0. 2 2 H ex ag on M al ar ia C om bi 58 02 4 H um an G m bH 46 .8 0. 0 97 .5 50 .0 0. 0 0. 0 (7 9) 0. 0 (1 57 ) 2. 6 (3 8) 3. 0 (1 67 ) 0. 7 1 H iS en s M al ar ia A g P. f/ P. v Ca rd H R2 82 3 H BI C o. , L td . 20 .0 15 .0 94 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2 H iS en s M al ar ia A g Pf /P v (H RP 2/ pL DH ) C ar d H R2 92 3 H BI C o. , L td . 84 .0 75 .0 99 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 5 0. 0 2 IC T Di ag no st ic s M al ar ia C om bo j M L0 2 IC T Di ag no st ic s 84 .9 8. 6 98 .0 91 .4 0. 0 3. 6 0. 0 5. 7 2. 5 0. 0 3 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 78 .8 60 .0 99 .0 97 .1 0. 5 (3 94 ) 0. 0 0. 0 1. 4 0. 5 (1 99 ) 0. 3 3 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 75 .8 17 .1 98 .0 94 .3 1. 8 (3 95 ) 5. 1 (1 38 ) 0. 0 0. 0 2. 0 0. 3 3 Im m un oq ui ck M al ar ia + 4 05 06 _K 25 Bi os yn ex 93 .7 30 .0 98 .7 10 0. 0 0. 0 (3 14 ) 0. 0 0. 0 (1 57 ) 0. 0 0. 6 0. 0 1 M al ar ia P .F /V iv ax 17 21 1O P- 25 Di ag no st ic s Au to m at io n/ Co rt ez Di ag no st ic s, In c. 73 .6 (5 3) 0. 0 (1 5) 94 .9 (3 9) 30 .8 (1 3) 1. 0 (9 7) 0. 0 (3 0) 2. 1 (4 8) 0. 0 (1 8) 1. 6 (6 4) 67 .5 1 M al ar ia P an T es t M AL -W 23 N- 00 1 Di m a • G es el lsc ha ft fü r D ia gn os tik a m bH 54 .6 0. 0 97 .0 48 .6 2. 8 15 .7 0. 0 17 .1 44 .0 0. 0 3 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic ej M FV -1 24 R AZ OG , I nc . 95 .0 0. 0 10 0. 0 94 .3 0. 0 (3 95 ) 7. 9 8. 1 0. 0 5. 5 (1 99 ) 0. 3 3 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 2. 0 5. 7 70 .7 97 .1 0. 0 (3 94 ) 0. 0 (1 39 ) 0. 0 0. 0 0. 0 (1 98 ) 0. 4 3 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa nj 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 82 .8 57 .1 97 .0 10 0. 0 1. 0 (3 92 ) 0. 7 (1 36 ) 1. 0 (1 94 ) 0. 0 (6 8) 1. 0 (1 95 ) 1. 9 3 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 77 .8 0. 0 10 0. 0 91 .4 0. 0 2. 9 0. 0 (1 97 ) 2. 9 0. 5 0. 0 3 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 6. 1 8. 6 89 .9 10 0. 0 0. 5 0. 0 (1 39 ) 0. 0 0. 0 0. 0 0. 1 3 On e St ep M al ar ia A nt ig en S tr ip 82 0- 1 IN D Di ag no st ic In c. 1. 3 0. 0 67 .1 60 .0 2. 2 3. 8 1. 9 0. 0 1. 8 (1 67 ) 0. 0 1 On e St ep M al ar ia P .f/ Pa n Te st j W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 37 .4 85 .7 95 .0 10 0. 0 8. 4 (3 83 ) 0. 0 (1 37 ) 0. 0 (1 94 ) 0. 0 (6 8) 4. 1 (1 95 ) 2. 4 3 On Si gh t™ – P ar aQ ui ck (P an , P f) Te st 53 6- 25 DB Am ge ni x In te rn at io na l, In c. 59 .5 50 .0 10 0. 0 10 0. 0 0. 0 1. 3 0. 0 0. 0 0. 0 0. 0 1 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 83 .8 85 .7 10 0. 0 10 0. 0 1. 3 0. 0 0. 0 0. 0 27 .5 0. 0 3 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 50 .5 97 .1 96 .0 68 .6 1. 5 0. 0 0. 5 20 .3 (6 9) 2. 0 (1 98 ) 0. 5 3 Pa ra H IT ® to ta l ( di ps tic k) 55 IC 20 1- 10 Sp an D ia gn os tic s Lt d 64 .0 10 .0 99 .0 97 .5 0. 0 0. 0 0. 0 0. 0 7. 0 0. 0 2 Pa ra hi t- To ta l D ev ic e Ra pi d te st fo r P . f al ci pa ru m a nd P an m al ar ia l s pe ci es . 25 98 9 Sp an D ia gn os tic s Lt d. 35 .4 0. 0 93 .7 50 .0 0. 0 (3 15 ) 0. 0 0. 0 2. 5 0. 0 0. 2 1 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 89 .9 45 .7 97 .0 88 .6 1. 0 (3 94 ) 2. 1 0. 0 (1 97 ) 7. 1 3. 5 (1 99 ) 0. 4 3 Qu ic ks tic k M al ar ia A nt ig en T es t -- In no va te k M ed ic al In c. 1. 3 0. 0 67 .1 60 .0 2. 2 3. 8 1. 9 0. 0 1. 8 (1 67 ) 0. 0 1 SD B IO LI N E M al ar ia A g P. f/ Pa nj 05 FK 60 St an da rd D ia gn os tic s In c. 92 .9 97 .1 99 .0 10 0. 0 0. 5 (3 94 ) 0. 0 0. 5 0. 0 3. 5 (1 99 ) 0. 3 3 SD B IO LI N E M al ar ia A gj 05 FK 40 St an da rd D ia gn os tic s In c. 16 .2 97 .1 93 .9 10 0. 0 0. 8 0. 0 0. 0 0. 0 0. 0 0. 0 3 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 83 .8 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 3 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 86 .9 0. 0 10 0. 0 5. 7 15 .7 (3 95 ) 5. 7 8. 1 (1 97 ) 4. 3 18 .5 0. 2 3 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 77 .8 31 .4 99 .0 10 0. 0 0. 5 0. 7 0. 0 0. 0 0. 0 0. 0 3 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 92 .9 97 .1 98 .0 10 0. 0 0. 3 0. 7 1. 5 (1 97 ) 0. 0 4. 0 0. 0 3 Ca re St ar t™ M al ar ia H RP 2/ PL DH (P f/ Pv ) C OM BO G 01 61 Ac ce ss B io , I nc . 90 .0 90 .0 10 0. 0 10 0. 0 0. 3 0. 6 0. 0 0. 0 0. 5 0. 0 2 Ca re St ar t™ M al ar ia H RP 2/ PL DH (P f/ VO M ) C OM BO G 01 71 Ac ce ss B io , I nc . 89 .0 80 .0 10 0. 0 10 0. 0 1. 3 0. 0 0. 5 0. 0 0. 5 0. 0 2 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)8 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or ea Fa lse p os iti ve r at es (% ) To ta l f al se p os iti ve ra te sb (% ) In va lid ra te (% ) (n =1 20 4) Ro un d 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 o r 50 00 pa ra sit es /µ l Cl ea n- ne ga tiv e sa m pl es Pf samples c Pv samples d Pf samples c Pv samples d Pf s am pl es Pv s am pl es Pf s am pl es Pv s am pl es Fa ls e po si tiv e no n- Pf in fe ct io ne Fa ls e po si tiv e Pf in fe ct io nf Fa ls e po si tiv e no n- Pf in fe ct io ng Fa ls e po si tiv e Pf in fe ct io nh Fa lse p os iti ve Pl as m od iu m sp p. In fe ct io ni Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 98 .0 60 .0 10 0. 0 97 .1 0. 3 0. 0 0. 0 0. 0 4. 0 0. 1 3 di ag no st ic ks - M al ar ia (P v/ Pf ) C as se tt e KM VF C6 00 2 SS A Di ag no st ic s & B io te ch S ys te m s 91 .0 45 .0 99 .0 10 0. 0 0. 3 (3 99 ) 0. 6 0. 0 0. 0 2. 0 0. 1 2 Fa lc iv ax R ap id T es t f or M al ar ia P v/ Pf (d ev ic e) 50 30 00 25 Ze ph yr B io m ed ic al s 92 .0 45 .0 10 0. 0 10 0. 0 0. 0 1. 3 0. 0 0. 0 (7 9) 4. 5 0. 2 2 Fi rs tS ig n™ – P ar aV ie w -2 (P v + Pf ) C ar d Te st 21 02 CB -2 5 U ni m ed In te rn at io na l, In c. 48 .1 0. 0 98 .7 85 .0 1. 0 3. 8 N /A 5. 0 0. 0 (1 67 ) 0. 0 1 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 79 .8 0. 0 10 0. 0 20 .0 0. 0 1. 4 0. 0 0. 0 0. 0 (1 99 ) 0. 1 3 M al er is ca n® M al ar ia P f/ Pv M AT -5 0 Bh at B io -T ec h In di a (P ) L td 52 .0 0. 0 97 .0 60 .0 1. 8 (3 99 ) 2. 5 32 .5 2. 5 (7 9) 1. 5 (1 99 ) 0. 4 2 On Si gh t™ - P ar aQ ui ck -2 (P v,P f) M al ar ia T es t 53 7- 25 -D B Am ge ni x In te rn at io na l, In c. 92 .0 37 .5 10 0. 0 10 0. 0 0. 5 1. 9 0. 0 0. 0 3. 5 0. 1 2 On Si te M al ar ia P f/ Pv A g Ra pi d Te st j R0 11 2C CT K Bi ot ec h, In c. 84 .9 97 .1 10 0. 0 10 0. 0 5. 3 0. 0 6. 1 0. 0 28 .0 0. 0 3 SD B IO LI N E M al ar ia A g Pf /P v 05 FK 80 St an da rd D ia gn os tic s, In c. 96 .0 95 .0 10 0. 0 10 0. 0 0. 0 0. 0 (1 59 ) 0. 0 (1 99 ) 0. 0 3. 5 0. 2 2 Pf , P v an d Pa n Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 92 .9 11 .4 99 .0 94 .3 0. 3 (3 91 ) 0. 0 (1 37 ) 0. 0 (1 97 ) 1. 4 3. 5 (1 98 ) 1. 0 3 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7.5 SS A Di ag no st ic s & B io te ch S ys te m s 93 .9 11 .4 99 .0 94 .3 0. 0 (3 89 ) 0. 0 (1 39 ) 0. 0 (1 96 ) 2. 9 (6 9) 4. 0 (1 99 ) 1. 1 3 Fi rs tS ig n™ - P ar aV ie w -3 (P an +P v+ Pf ) M al ar ia T es t 21 03 C B- 25 U ni m ed In te rn at io na l I nc . 89 .0 45 .0 10 0. 0 10 0. 0 0. 0 (3 99 ) 2. 5 0. 0 0. 0 24 .5 0. 1 2 Pa ra m ax -3 R ap id T es t f or M al ar ia P an /P v/ Pf (d ev ic e) 50 32 00 25 Ze ph yr B io m ed ic al s 93 .0 45 .0 10 0. 0 10 0. 0 0. 0 (3 96 ) 0. 0 (1 59 ) 0. 0 (1 99 ) 0. 0 37 .0 (1 98 ) 0. 7 2 Pa n on ly Ad va nt ag e Pa n M al ar ia C ar d IR 01 30 25 J. M itr a & C o. P vt . L td . 72 .2 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A 1. 8 0. 0 1 Ca re St ar t™ M al ar ia p LD H (P AN ) G 01 11 Ac ce ss B io , I nc . 92 .4 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A 6. 6 0. 0 1 Cl ea rv ie w ® M al ar ia p LD H j 70 88 40 25 Or ge ni cs L td . 81 .8 85 .7 99 .0 10 0. 0 N /A N /A N /A N /A 13 .5 0. 5 3 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 16 .2 54 .3 92 .9 10 0. 0 N /A N /A N /A N /A 0. 0 0. 3 3 Fi rs t R es po ns e® M al ar ia A g pL DH I1 2F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. 31 .0 92 .5 98 .0 10 0. 0 N /A N /A N /A N /A 0. 0 0. 0 2 Fi rs tS ig n™ - P an Ch ec k (P an ) M al ar ia T es t 21 04 C B- 25 U ni m ed In te rn at io na l I nc . 25 .0 82 .5 87 .0 10 0. 0 N /A N /A N /A N /A 2. 5 0. 2 2 On Si gh t™ - P an Sc re en (P an ) M al ar ia T es t 53 9- 25 -D B Am ge ni x In te rn at io na l, In c. 22 .0 77 .5 96 .0 10 0. 0 N /A N /A N /A N /A 2. 5 0. 2 2 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an j 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 17 .2 62 .9 90 .9 10 0. 0 N /A N /A N /A N /A 0. 5 0. 2 3 Pv o nl y SD B IO LI N E M al ar ia A g Pv 05 FK 70 St an da rd D ia gn os tic s, In c. N /A 92 .5 N /A 10 0. 0 0. 3 N /A 1. 0 N /A 1. 0 0. 0 2 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a A sa m pl e is c on si de re d de te ct ed o nl y if al l R DT s fr om b ot h lo ts re ad b y th e fir st te ch ni ci an , a t m in im um s pe ci fie d re ad in g tim e, a re p os iti ve b Th e to ta l n um be r o f t im es a p os iti ve re su lt fo r m al ar ia w as g en er at ed w he n it sh ou ld n ot h av e be en c Ro un d 1, n =7 9; R ou nd 2 , n =1 00 ; R ou nd 3 , n =9 9 d Ro un d 1, n =2 0; R ou nd 2 , n =4 0; R ou nd 3 , n =3 5 e Fo r c om bi na tio n te st s, Pa n or P v lin e, o nl y, po si tiv e in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n (R ou nd 1 n =3 16 ; R ou nd 2 , n =4 00 ; R ou nd 3 , n =3 96 ) f Pf li ne p os iti ve in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n (R ou nd 1 , n =8 0; Ro un d 2, n =1 60 ; R ou nd 3 , n =1 40 )       g Fo r c om bi na tio n te st s, Pa n or P v lin e, o nl y, po si tiv e in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n (R ou nd 1 , n =1 58 , R ou nd 2 , n =2 00 ; R ou nd 3 , n =1 98 ) h Pf li ne p os iti ve in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n (R ou nd 1 , n =4 0; Ro un d 2, n =8 0, R ou nd 3 , n =7 0) i Ro un d 1, n =1 68 ; R ou nd 2 , n =2 00 ; R ou nd 3 , n =2 00 j Pr od uc t r es ub m is si on , r es ul ts fr om m os t r ec en t r ou nd o f t es tin g re pl ac e pr ev io us re su lts . R ef er to T ab le S 3. k PD S pr es en te d in th e ta bl e is b as ed o n a po si tiv e pf te st li ne (e ith er p f- H RP 2 or pf -p LD H ). P. fa lc ip ar um P DS b as ed o n in di vi du al te st li ne s w as : pf -p LD H (1 7. 2% a t 20 0p /µ l; 97 % a t 2 00 0p /µ l) an d pf -H RP 2 (8 7. 9% a t 2 00 p/ µl ; 1 00 % a t 2 00 0p /µ l)    De te ct io n ra te (% ) ≥9 5 85 -9 4 50 -8 4 < 50 Fa ls e po si tiv e ra te (% ) <2 2- 5 6 -1 0 >1 0 In va lid ra te (% ) <1 % o f t es ts co nd uc te d 1- 2% o f t es ts co nd uc te d 2- 5% o f t es ts co nd uc te d >5 % o f t es ts co nd uc te d   Ta bl e S1 ( co nt in ue d) sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 9 Ta bl e S2 : M al ar ia R DT R ou nd s 1- 3 he at s ta bi lit y re su lt s on a c ul tu re d P. f al ci pa ru m s am pl e at lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns it y (p ar as it es /µ l) . Po si ti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Ro un d 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st a IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Ad va nc ed Q ua lit y™ M al ar ia (p .f) P OC T IT P1 10 02 TC 1 In Te c Pr od uc ts , I nc . 80 .0 95 .0 90 .0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 Ad va nt ag e P. f. M al ar ia C ar d IR 01 60 25 J. M itr a & C o. P vt . L td . 95 .0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 10 0. 0 10 0. 0 86 .7 10 0. 0 90 .0 80 .0 N /A N /A N /A N /A N /A N /A 3 Ca re St ar t™ M al ar ia H RP 2 (P f) G 01 41 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 Ca re St ar t™ M al ar ia H RP 2/ pL DH P f t es t G 01 81 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 Cl ea rv ie w ® M al ar ia P .f. a VB 01 Vi si on B io te ch (P ty ) L td 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 di ag no st ic ks - M al ar ia (P f) Ca ss et te KM FC 60 01 SS A Di ag no st ic s & B io te ch S ys te m s 95 .0 70 .0 55 .0 95 .0 95 .0 95 .0 N /A N /A N /A N /A N /A N /A 2 di ag no st ic ks - M al ar ia (P f) Di ps tic k K M FD 60 07 SS A Di ag no st ic s & B io te ch S ys te m s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 Fi rs t R es po ns e® M al ar ia A g H RP 2 I1 3F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 Fi rs tS ig n™ – M al ar ia P f C ar d Te st -- U ni m ed In te rn at io na l, In c. 20 .0 15 .0 0. 0 10 0. 0 90 .0 95 .0 N /A N /A N /A N /A N /A N /A 1 H ex ag on M al ar ia 58 05 1 H um an G m bH 50 .0 35 .0 60 .0 95 .0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 H iS en s M al ar ia A g Pf H RP 2 Ca rd H R3 02 3 H BI C o. , L td . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 IC T Di ag no st ic s M al ar ia P .f. a M L0 1 IC T Di ag no st ic s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Im m un oq ui ck M al ar ia F al ci pa ru m 05 02 _K 25 Bi os yn ex 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 M al ar ia P la sm od iu m fa lc ip ar um R ap id te st D ev ic e (W ho le b lo od ) IM A- 40 2 AC ON L ab or at or ie s, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 96 .7 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 On e St ep M al ar ia P .F T es t ( ca ss et te )a 52 23 52 Bl ue C ro ss B io -M ed ica l ( Be iji ng ) C o. , L td . 63 .3 0. 0 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 On e St ep M al ar ia P .f Te st a W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 10 0. 0 93 .3 90 .0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 On Si gh t™ - M al ar ia P f T es t 51 1- 25 -D B Am ge ni x In te rn at io na l, In c. 10 0. 0 95 .0 90 .0 10 0. 0 10 0. 0 65 .0 N /A N /A N /A N /A N /A N /A 2 On Si te P f A g Ra pi d Te st a R0 11 4C CT K Bi ot ec h, In c. 96 .7 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 a 30 30 10 25 Or ch id B io m ed ic al S ys te m s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 a 30 30 20 25 Or ch id B io m ed ic al S ys te m s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Pa ra H IT ® - f ( De vi ce )a 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 90 .0 N /A N /A N /A N /A N /A N /A 3 Pa ra H IT ® -f (D ip st ic k) a 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 10 0. 0 10 0. 0 56 .7 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )b 05 FK 90 St an da rd D ia gn os tic s In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 SD B IO LI N E M al ar ia A g Pf 05 FK 50 St an da rd D ia gn os tic s, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 1 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 10 0. 0 80 .0 90 .0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 Ad va nt ag e M al C ar d IR 22 10 25 J. M itr a & C o. P vt . L td . 10 0. 0 10 0. 0 55 .0 95 .0 10 0. 0 95 .0 55 .0 45 .0 40 .0 10 0. 0 10 0. 0 10 0. 0 1 Bi na x N ow M al ar ia T es t IN 66 00 50 In ve rn es s M ed ic al In no va tio ns , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 95 .0 5. 0 0. 0 0. 0 95 .0 95 .0 75 .0 1 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 10 0. 0 90 .0 3 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io In c 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 3 Ca re St ar t™ M al ar ia H RP 2/ pL DH (P f/ PA N ) C OM BO G 01 31 Ac ce ss B io , I nc . 10 0. 0 95 .0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 95 .0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 1 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)10 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Ro un d 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 93 .3 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 93 .3 10 0. 0 10 0. 0 10 0. 0 3 Cl ea rv ie w ® M al ar ia C om bo a VB 11 Vi si on B io te ch (P ty ) L td 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 90 .0 20 .0 0. 0 3 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic ea VB 20 Vi si on B io te ch (P ty ) L td 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 50 .0 90 .0 20 .0 3 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 90 .0 90 .0 3 Fi rs t R es po ns e® M al ar ia p LD H /H RP 2 Co m bo T es ta I1 6F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 85 .0 55 .0 55 .0 10 0. 0 10 0. 0 10 0. 0 2 Fi rs tS ig n™ - P ar aV ie w (P an +P f) M al ar ia T es t 21 01 C B- 25 U ni m ed In te rn at io na l I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 95 .0 40 .0 40 .0 10 0. 0 10 0. 0 10 0. 0 2 H ex ag on M al ar ia C om bi 58 02 4 H um an G m bH 65 .0 55 .0 50 .0 10 0. 0 85 .0 95 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1 H iS en s M al ar ia A g P. f/ P. v Ca rd H R2 82 3 H BI C o. , L td . 35 .0 0. 0 5. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 35 .0 0. 0 0. 0 2 H iS en s M al ar ia A g Pf /P v (H RP 2/ pL DH ) C ar d H R2 92 3 H BI C o. , L td . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 95 .0 10 0. 0 10 0. 0 10 0. 0 2 IC T Di ag no st ic s M al ar ia C om bo a M L0 2 IC T Di ag no st ic s 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 90 .0 0. 0 0. 0 0. 0 90 .0 30 .0 0. 0 3 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 10 0. 0 10 0. 0 93 .3 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 80 .0 0. 0 3 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 50 .0 50 .0 10 0. 0 3 Im m un oq ui ck M al ar ia + 4 05 06 _K 25 Bi os yn ex 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 80 .0 80 .0 1 M al ar ia P .F /V iv ax 17 21 1O P- 25 Di ag no st ic s Au to m at io n/ Co rt ez Di ag no st ic s, In c. 65 .0 15 .0 20 .0 65 .0 45 .0 5. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1 M al ar ia P an T es t M AL -W 23 N- 00 1 Di m a • Ge se lls ch af t f ür D ia gn os tik a m bH 60 .0 33 .3 23 .3 10 0. 0 10 0. 0 90 .0 13 .3 53 .3 40 .0 10 .0 60 .0 40 .0 3 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic ea M FV -1 24 R AZ OG , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 3. 3 0. 0 0. 0 40 .0 10 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa na 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 96 .7 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 6. 7 10 0. 0 10 0. 0 10 0. 0 3 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 90 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 N an oS ig n M al ar ia P f/ Pv A g RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 20 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 On e St ep M al ar ia A nt ig en S tr ip 82 0- 1 IN D Di ag no st ic In c. 15 .0 0. 0 0. 0 65 .0 50 .0 0. 0 15 .0 0. 0 0. 0 65 .0 50 .0 5. 0 1 On e St ep M al ar ia P .f/ Pa n Te st a W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 46 .7 13 .3 26 .7 10 0. 0 10 0. 0 10 0. 0 0. 0 36 .7 73 .3 70 .0 80 .0 10 0. 0 3 On Si gh t™ – P ar aQ ui ck (P an , P f) Te st 53 6- 25 DB Am ge ni x In te rn at io na l, In c. 10 0. 0 90 .0 60 .0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 10 0. 0 95 .0 1 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 3. 3 66 .7 83 .3 10 0. 0 10 0. 0 80 .0 3 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 10 0. 0 90 .0 0. 0 0. 0 0. 0 0. 0 10 0. 0 90 .0 0. 0 3 Pa ra H IT ® to ta l ( di ps tic k) 55 IC 20 1- 10 Sp an D ia gn os tic s Lt d 55 .0 85 .0 55 .0 10 0. 0 10 0. 0 95 .0 10 .0 0. 0 0. 0 50 .0 45 .0 70 .0 2 Pa ra hi t- To ta l D ev ic e Ra pi d te st fo r P . f al ci pa ru m a nd P an m al ar ia l s pe ci es 25 98 9 Sp an D ia gn os tic s Lt d. 65 .0 75 .0 25 .0 95 .0 10 0. 0 10 0. 0 5. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 90 .0 10 0. 0 10 0. 0 3 Qu ic ks tic k M al ar ia A nt ig en T es t -- In no va te k M ed ic al In c. 15 .0 0. 0 0. 0 65 .0 50 .0 0. 0 15 .0 0. 0 0. 0 65 .0 50 .0 5. 0 1 SD B IO LI N E M al ar ia A g P. f/ Pa na 05 FK 60 St an da rd D ia gn os tic s In c. 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 10 0. 0 70 .0 90 .0 3 SD B IO LI N E M al ar ia A ga 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 10 0. 0 80 .0 90 .0 0. 0 0. 0 0. 0 80 .0 20 .0 90 .0 3 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 96 .7 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 10 0. 0 96 .7 96 .7 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 Ca re St ar t™ M al ar ia H RP 2/ PL DH (P f/ Pv ) C OM BO G 01 61 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 95 .0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 Ta bl e S2 ( co nt in ue d) sU M M ar Y r o U n d s 1- 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 11 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P f lin e) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Pe rc en t po sit iv e te st r es ul ts fo r P. f al ci pa ru m (P an li ne ) Ro un d 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve N um be r of t es ts p os iti ve Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Ca re St ar t™ M al ar ia H RP 2/ PL DH (P f/ VO M ) C OM BO G 01 71 Ac ce ss B io , I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 di ag no st ic ks - M al ar ia (P v/ Pf ) C as se tt e KM VF C6 00 2 SS A Di ag no st ic s & B io te ch S ys te m s 10 0. 0 95 .0 95 .0 10 0. 0 10 0. 0 95 .0 N /A N /A N /A N /A N /A N /A 2 Fa lc iv ax R ap id T es t f or M al ar ia P v/ Pf (d ev ic e) 50 30 00 25 Ze ph yr B io m ed ic al s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 2 Fi rs tS ig n™ – P ar aV ie w -2 (P v + Pf ) C ar d Te st 21 02 CB -2 5 U ni m ed In te rn at io na l, In c. 95 .0 70 .0 0. 0 10 0. 0 95 .0 75 .0 N /A N /A N /A N /A N /A N /A 1 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 10 0. 0 10 0. 0 96 .7 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 M al er is ca n® M al ar ia P f/ Pv M AT -5 0 Bh at B io -T ec h In di a (P ) L td 10 0. 0 60 .0 30 .0 10 0. 0 90 .0 95 .0 N /A N /A N /A N /A N /A N /A 2 On Si gh t™ - P ar aQ ui ck -2 (P v,P f) M al ar ia T es t 53 7- 25 -D B Am ge ni x In te rn at io na l, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 85 .0 N /A N /A N /A N /A N /A N /A 2 On Si te M al ar ia P f/ Pv A g Ra pi d Te st a R0 11 2C CT K Bi ot ec h, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 N /A N /A N /A N /A N /A N /A 3 SD B IO LI N E M al ar ia A g Pf /P v 05 FK 80 St an da rd D ia gn os tic s, In c. 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 95 .0 N /A N /A N /A N /A N /A N /A 2 Pf , P v an d Pa n Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 90 .0 10 0. 0 0. 0 0. 0 0. 0 80 .0 50 .0 70 .0 3 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 96 .7 10 0. 0 93 .3 10 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 70 .0 0. 0 50 .0 3 Fi rs tS ig n™ - P ar aV ie w -3 (P an +P v+ Pf ) M al ar ia T es t 21 03 C B- 25 U ni m ed In te rn at io na l I nc . 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 60 .0 50 .0 15 .0 10 0. 0 90 .0 10 0. 0 2 Pa ra m ax -3 R ap id T es t f or M al ar ia P an /P v/ Pf (d ev ic e) 50 32 00 25 Ze ph yr B io m ed ic al s 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 25 .0 30 .0 10 0. 0 95 .0 10 0. 0 2 Pa n O nl y Ad va nt ag e Pa n M al ar ia C ar d IR 01 30 25 J. M itr a & C o. P vt . L td . N /A N /A N /A N /A N /A N /A 50 .0 65 .0 70 .0 10 0. 0 10 0. 0 10 0. 0 1 Ca re St ar t™ M al ar ia p LD H (P AN ) G 01 11 Ac ce ss B io , I nc . N /A N /A N /A N /A N /A N /A 10 0. 0 10 0. 0 90 .0 10 0. 0 10 0. 0 10 0. 0 1 Cl ea rv ie w ® M al ar ia p LD H a 70 88 40 25 Or ge ni cs L td . N /A N /A N /A N /A N /A N /A 96 .7 93 .3 10 0. 0 10 0. 0 10 0. 0 10 0. 0 3 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s N /A N /A N /A N /A N /A N /A 0. 0 0. 0 0. 0 80 .0 10 0. 0 80 .0 3 Fi rs t R es po ns e® M al ar ia A g pL DH I1 2F RC 30 Pr em ie r M ed ic al C or po ra tio n Lt d. N /A N /A N /A N /A N /A N /A 50 .0 80 .0 55 .0 10 0. 0 10 0. 0 10 0. 0 2 Fi rs tS ig n™ - P an Ch ec k (P an ) M al ar ia T es t 21 04 C B- 25 U ni m ed In te rn at io na l I nc . N /A N /A N /A N /A N /A N /A 25 .0 5. 0 10 .0 10 0. 0 10 0. 0 10 0. 0 2 On Si gh t™ - P an Sc re en (P an ) M al ar ia T es t 53 9- 25 -D B Am ge ni x In te rn at io na l, In c. N /A N /A N /A N /A N /A N /A 5. 0 35 .0 15 .0 10 0. 0 10 0. 0 10 0. 0 2 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an a 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A 0. 0 0. 0 0. 0 90 .0 10 0. 0 10 0. 0 3 Pv o nl y SD B IO LI N E M al ar ia A g Pv 05 FK 70 St an da rd D ia gn os tic s, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 2 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Pr od uc t r es ub m is si on , r es ul ts fr om m os t r ec en t r ou nd o f t es tin g re pl ac e pr ev io us re su lts . R ef er to T ab le S 3. b Re su lts p re se nt ed in th e ta bl e ar e ba se d on s ta bi lit y of a p f t es t l in e (e ith er p f- H RP 2 or p f- pL DH ). Re su lts b as ed o n st ab ili ty o f i nd iv id ua l t es t l in es o n 20 0p /µ l a nd 2 00 0p /µ l s am pl es w er e, re sp ec tiv el y : p f- pL DH (0 % ; 3 3. 3% d et ec te d at b as el in e an d 0% ; 33 .3 % d et ec te d po st 6 0 d in cu ba tio n at 3 5° C, 4 5° C) a nd p f- H RP 2 (1 00 % ; 1 00 % a t b as el in e an d 10 0% ; 1 00 % p os t 6 0 d in cu ba tio n at 3 5° C, 4 5° C) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)12 Ta bl e S3 : P ro du ct R es ub m is si on s: W H O M al ar ia R DT P ro du ct T es tin g - Ro un ds 1 -3 M an uf ac tu re r In iti al T es tin g Su bs eq ue nt T es tin g Ro un d Pr od uc t N am e Ca ta lo gu e N o Ro un d Pr od uc t N am e Ca ta lo gu e N o AZ OG , I nc . 1 M al ar ia P f ( H RP II) /p v- LD H ) A nt ig en D et ec tio n Te st D ev ic ea M FV -1 24 R 3 M al ar ia p f ( H RP II ) / (P AN -L DH ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 2 On e St ep M al ar ia P f T es t ( ca ss et te ) 52 23 52 3 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 CT K Bi ot ec h, In c. 2 On si te P f A g Ra pi d Te st R0 11 4C 3 On Si te P f A g Ra pi d Te st R0 11 4C 2 On si te P f/ Pa n Ag R ap id T es t R0 11 3C 3 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C 2 On si te P f/ Pv A g Ra pi d Te st R0 11 2C 3 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C Di aM ed - A D iv is io n of B io -R ad 1 Op tiM AL -I T 71 00 24 3 Op tiM AL -I T 71 00 24 G ua ng zh ou W on df o Bi ot ec h Co . L td . 1 W on df o On e St ep M al ar ia P f/ Pa n W ho le B lo od T es t W 56 -C (4 .0 m m ) 3 On e St ep M al ar ia P .f. /P an W ho le B lo od T es t W 56 -C 2 On e St ep M al ar ia P .f Te st b W 37 -C (4 .0 m m ) 3 On e St ep M al ar ia P .f Te st W 37 -C IC T Di ag no st ic s 1 IC T M al ar ia C om bo C as se tt e Te st M L0 2 3 IC T Di ag no st ic s M al ar ia C om bo M L0 2 1 IC T M al ar ia P f C as se tt e Te st M L0 1 3 IC T Di ag no st ic s M al ar ia P .f M L0 1 In Te c Pr od uc ts , I nc . 1 AD VA N CE D QU AL IT Y™ O ne S te p M al ar ia (p .f. ) T es t ( w ho le b lo od ) IT P1 10 02 TC 40 3 Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 T C4 0 Or ch id B io m ed ic al S ys te m s 1 Pa ra ch ec k Pf R ap id te st fo r P .fa lc ip ar um M al ar ia (D ev ic e) 30 30 10 25 3 Pa ra ch ec k® P f D ev ic e - Ra pi d te st fo r P . f al ci pa ru m M al ar ia (V er . 3 ) 30 30 10 25 1 Pa ra ch ec k Pf R ap id te st fo r P .fa lc ip ar um M al ar ia (D ip st ic k) 30 30 20 25 3 Pa ra ch ec k® P f D ip st ic k - Ra pi d te st fo r P . f al ci pa ru m M al ar ia (V er .3 ) 30 30 20 25 Pr em ie r M ed ic al C or po ra tio n Lt d. 1 Fi rs t R es po ns e M al ar ia A g Co m bo (p LD H /H RP 2) II6 FR C3 0 2 Fi rs t R es po ns e® M al ar ia A g Co m bo (p LD H /H RP 2) I1 6F RC 30 Sp an D ia gn ot ic s Lt d. 1 Pa ra hi t- f T ES T DE VI CE F OR F AL CI PA RU M M AL AR IA 25 97 5 3 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 10 1 Pa ra hi t- f D IP ST IC K FO R FA LC IP AR U M M AL AR IA 25 97 7 3 Pa ra H IT ® - f ( Di ps tic k) 55 IC 10 1- 10 St an da rd D ia gn os tic s In c. (n ow A le re H ea lth ca re (P ty ) L td ) 1 SD B IO LI N E M al ar ia A g 0 5F K4 0- 02 -5 d 3 SD B IO LI N E M al ar ia A g 05 FK 40 1 SD B IO LI N E M al ar ia A g Pf /P an 05 FK 60 -0 2- 3d 3 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 Vi si on B io te ch (P ty ) L td (n ow A le re H ea lth ca re (P ty ) L td ) 1 M al ar ia R ap id C om bo VB 01 1 3 Cl ea rv ie w ® M al ar ia C om bo VB 11 e 1 M al ar ia R ap id P f VB 01 3 Cl ea rv ie w ® M al ar ia P f VB 01 1 M al ar ia R ap id D ua l VB 02 0 3 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 e Ze ph yr B io m ed ic al S ys te m s 1 M al as ca n Ra pi d Te st fo r M al ar ia P f/ Pa n (D ev ic e) 50 40 20 25 3 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 1 Pa ra ba nk R ap id T es t f or M al ar ia P an (D ev ic e) 50 30 10 25 3 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 1 Pa ra sc re en R ap id T es t f or M al ar ia P an /P f ( De vi ce ) 50 31 00 25 3 Pa ra sc re en ™ D ev ic e -R ap id te st fo r M al ar ia P an /P f 50 31 00 25 a Ro un d 1 pr od uc t n am e er ro r : p ub lis he d - M al ar ia P f ( H RP II) /p v- LD H ) A nt ig en D et ec tio n Te st D ev ic e Co de ; co rr ec te d pr od uc t n am e: M al ar ia P f ( H RP II/ PA N -L DH ) A nt ig en D et ec tio n Te st D ev ic e Co de . N o ch an ge in p ro du ct c od e. b In R ou nd 2 , p ro du ct d id n ot p as s Ph as e 1, th er ef or e re su lts d o no t f ea tu re in S um m ar y ta bl es . c Er ro r i n W H O M al ar ia R DT P ro du ct T es tin g: R ou nd 1 re po rt : p ro du ct c od e (II 6F RC 30 ) s ho ul d ha ve b ee n ( I 16 FR C3 0 ), as in R ou nd 2 d 02 -0 5/ 02 -0 3 su ffi x re fe rs to v er si on o f t he p ac ka ge in se rt s e N ew c om pa ny a cq ui si tio n (A le re ™ ) - he nc e na m e ch an ge s/ pr od uc t c od es . M an uf ac tu re r c on fir m ed c om pl ia nc e w ith p ro du ct d efi ni tio n. eX ec U ti Ve s U M M ar Y ro U n d 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 13 2.1. introduction The World Health Organization estimates that half the world’s population are at risk of malaria, with 225 million people developing clinical malaria in 2009 (78% in Africa), and 781,000 deaths (91% in Africa, most being children). Malaria remains endemic in 106 countries, , and while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly identified, resulting in over-use of anti- malarial drugs and poor disease monitoring (1). WHO recommends that malaria case management be based on parasite-based diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, providing the possibility of parasite- based diagnosis in areas where good quality microscopy cannot be maintained. The number of RDTs available, and the scale of their use, has rapidly increased over the past few years. However, limitations of comparative field trials and the heterogeneous nature of malaria transmission and epidemiology has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implemen- tation, and limits the ability to extrapolate results of field trials to different populations and time periods. To this end in 2006, the World Health Organization (WHO), Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched an evaluation programme to assess the comparative performance of commercially available malaria RDTs. This data is guiding procurement decisions and driving improvement in the quality of manufacturing. The results of the first round of Product Testing were published in April 2009, and presently form the basis of procurement criteria of WHO, other UN agencies and national governments (3). This Report provides data on Round 3 of Product Testing, performed at the United States Centers for Disease Control and Prevention, Division of Malaria and Parasitic Diseases (CDC) in 2010-2011. It provides performance data on 50 products. This evaluation should be seen as additive to the Round 1 and Round 2 evaluations published in 2009 and 2010 respectively (3,4). The three reports should be viewed together as a single evaluation, with the exception that where products tested in previous rounds have been re-submitted for testing in Rounds 2 or 3, the most recent result replace those reported previously. The evaluation panels were essentially equivalent, and the same testing protocols were followed. This report expands the data set from previous rounds, and therefore increases the number of RDTs available for procurement that have detailed comparative data on aspects of performance relevant to field use. 2.2. the WHo product testing programme Product Testing is part of the WHO-FIND Malaria RDT Evaluation Programme. This programme develops methods for evaluation and provides relevant data on antigen- detecting malaria rapid diagnostic tests. The programme is a collaboration of many institutions in malaria-endemic and non-endemic countries, with the global specimen bank maintained, and the testing performed, at CDC (Figure 2). All companies manufacturing under ISO 13485:2003 Quality System Standard were invited to submit up to two tests for evaluation under the programme. The 50 products from 23 manufacturers12 were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites and patient-derived, wild-type P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after two months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. As in previous rounds, RDTs are grouped in the result tables and figures into those detecting P. falciparum only, various combination tests, and those that have only a pan-specific (or P. vivax-specific) line. Manufacturers submitted two lots of each product for evaluation. The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement deci- sions of WHO and other UN agencies and national govern- ments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad implementation of reliable malaria diagnosis in areas where malaria is prevalent. A fourth round of product testing began in June 2011, and results will be published in 2012. 2.3. results of the evaluation The results (summarized in Tables 3, 4, 5 and Figures S1 and S2) provide comparative data on two lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/µl), considered close to the threshold that tests must detect to reliably identify clinical malaria in 12 Since their application for Round 3, several companies have been acquired by Alere™ (Table 1). 2. WHo Malaria rdt prodUct testing: roUnd 3 eXecUtiVe sUMMarY Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)14 many settings (5), and a higher parasite density (2000 (or 5000) parasites/µl). For the purposes of this report, the main measure of performance is the ‘panel detection score (PDS)’; the percentage of malaria samples in the panel giving a posi- tive result by two RDTs per lot at the lower parasite density, and a single RDT per lot at the higher parasite density. Thus, it is not a measure of RDT clinical sensitivity, or positivity rate against the panel but rather a combined measure of positivity rate, along with inter-test and inter-lot consistency. Consistent with the performance of products included in previous rounds of Product Testing, the PDS varies widely between products, with some products showing high perform- ance in detecting parasites, in thermal stability and other performance measures. Overall, there is no obvious trade-off seen between PDS (or positivity rate) and false-positive rate, these being surrogates for sensitivity and specificity in the field, respectively. Furthermore, a number of tests showed good outcomes on both of these indicators, more so than in previous rounds. Re-submitted products (23 of 50 evaluated) generally maintained high levels of perform- ance seen in earlier rounds or substantially increased their PDS. High false-positive rates are seen for several products against the blood samples containing specific immunological abnormalities (eg. rheumatoid factor, anti-mouse antibodies) However, the number of samples evaluated was small and the clinical significance of these results is limited, but may become important in certain populations with very low parasite prevalence. Some products show a variation in performance indicators between the two lots evaluated, underlining the advisability of lot-testing before field use. Heat (thermal) stability varies widely, with some products retaining high positivity rates after two months storage at 45ºC in 75% humidity. The clinical sensitivity of an RDT to detect malaria is highly dependent on the local conditions, including parasite density in the target population, and so will vary between popula- tions with differing levels of transmission. The results in this report show comparative performance between RDTs, and give an idea of which products are likely to provide higher sensitivity in the field, particularly in populations with low- density infections. In general, as countries reduce malaria prevalence and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the panel detection score at 2000 parasites/µl indicates, the sensitivity of many of these products will be similar in populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, those well protected by bed nets) and must always be taken into account when interpreting RDT results. In areas where significant levels of non-expression of HRP2 is known to occur, the results of HRP2-detecting tests given in this report should not be considered predictive of field sensitivity. Tests targeting P. falciparum by detection of pLDH or aldolase should only be considered. Heat stability (summarized in Table 5) is vital to maintaining sensitivity of the test in the field. As a result, for procurement, it is essential that careful consideration be given to stability results to ensure that products to be used in areas with high temperatures of transport and storage have demon- strated great stability in the product testing programme. Requirements will vary between countries: for example, if tests are to be deployed in areas where temperatures rarely rise above 30°C, less emphasis needs to be placed on stability at high temperatures. Ease of use requirements will also vary, depending on the extent of training and the work environment of the end-users. Particularly in primary health care settings, the simpler the tests, the easier it will be to avoid errors in preparation and interpretation. 2.4. Use of these results The results included in this report should be considered together with those of Round 1 (2008) and Round 2 (2009), with the results of re-submitted products replacing those reported in earlier rounds (3,4). Ultimately, it is imperative that procurement decisions based on these results take into consideration local conditions of malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen variation, parasite densities, climate). Procurement of RDTs must not occur without programmatic and infrastructure preparation for proper use, including supply chain management, training on test usage and disposal, and training on patient management in response to results. This report provides an algorithm to assist in this decision-making process (Annex 5a). Furthermore, comprehensive guidance on several aspects of procurement can be found in ‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’ (6). eX ec U ti Ve s U M M ar Y ro U n d 3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 15 3. backgroUnd In 2010, WHO estimated that 3.3 billion persons were at risk of acquiring malaria. Of these, 225 million people were infected in 2009 (78% in Africa), and 781,000 died (91% in Africa, most being children). Malaria remains endemic in 106 countries (1). In the past decade, major new opportunities for the control of malaria have emerged, including implementation of long-lasting insecticidal nets, indoor residual spraying of insecticides and artemisinin-based combination therapy (ACT). These tools, in combination with increased coverage of malaria control programs, are likely to reduce the burden of malaria infection in countries where they are adequately implemented. In turn, the proportion of febrile episodes attributable to malaria is likely to decrease substantially. Despite WHO recommendations for laboratory-confirmed diagnosis of malaria infections prior to treatment in all cases (2), diagnosis is often made on clinical grounds (5). However, in most endemic areas malaria makes up a minority of ‘malaria-like’ febrile illness. Microscopy has been the cornerstone of diagnosis and is recommended for malaria diagnosis where its quality can be maintained, but the need for trained personnel, adequate reagents and equipment, limit its availability and accessibility to many people in malaria- endemic areas. Rapid, accurate and accessible diagnostic tools are becoming increasingly important, as programmes expand parasite-based diagnosis and the prevalence of malaria decreases. In recent years, rapid diagnostic tests (RDTs), which detect Plasmodium-specific antigens (proteins) in whole blood of infected people, have emerged as an attractive alternative to microscopy. Currently available RDTs come in various formats (dipstick, cassette or card) and contain bound antibodies to specific antigens such as histidine-rich protein-2 (HRP2) (specific to P. falciparum), pan-specific or species-specific plasmodium lactate dehydrogenase (pLDH) or aldolase (specific to all the major Plasmodium species: P. falciparum, P. vivax, P. malariae, P. ovale (Figure 1). To be widely useful, a RDT must have high sensitivity to ensure all clinically-significant malaria infections are detected; high specificity to enable monitoring of low malaria prevalence and appropriate management of non-malarial fever; and high stability to allow transport and storage in ambient conditions in malaria-endemic areas. Published field trials of RDTs show high variability in performance, likely due to inadequate quality of manufacture, incorrect storage and handling, poor preparation and interpretation, and sometimes poor study methods, analysis and reporting (7-13). In general, diagnostic testing (by microscopy or RDT) to a level of 200 parasites/µl will reliably detect nearly all clinically relevant infections in malaria-endemic areas (5). The number of RDTs available on the market has grown rapidly since their introduction in the late 1990s. It is estimated that there are 60 brands and over 200 tests commercially available today, with an estimated 100 million tests or more financed in 201113 However, regulatory oversight of diagnostics is often weak, and procurement agencies have faced considerable problems in selecting appropriate RDTs and ensuring quality. In view of the inconsistency in field study results and the inherent difficulties in assessing large numbers of products in a standardized way through field trials, WHO and various partners embarked on a Malaria Rapid Diagnostic Test Product Evaluation Programme in 2002 to develop and employ standardized assessment of malaria 13 Tracking Progress in Scaling-Up Diagnosis and Treatment for Malaria. Geneva. 2009. Roll Back Malaria Partnership. Figure 1: Mode of action of antigen-detecting malaria RDTs a b c Bound Ab Free labelled Ab Captured Ag–labelled Ab complex Captured labelled Ab Parasite Ag captured by labelled Ab Labelled Ab–Ag complex captured by bound Ab of test band Lysing agent and labelled Ab Test line (bound Ab)* Parasitized blood Buer/ ushing agent Control line (bound Ab)* Nitrocellulose strip Blood and labelled Ab ushed along strip *Not normally visible Labelled Ab captured by bound Ab of control band Mode of action of common malaria RDT format: (a) Dye-labeled antibody (Ab), specific for target antigen, is present on the lower end of the nitrocellulose strip or in a well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labeled antibody, or antigen, is bound at the control line. (b) Blood and buffer, which have been placed on the strip or in the well, are mixed with the labeled antibody and are drawn up the strip across the lines of bound antibody. (c) If antigen is present, some labeled antibody will be trapped on the test line. Other labeled antibody is trapped on the control line. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)16 RDT performance, and to guide procurement decisions and regulatory mechanisms. The Programme has been overseen by WHO and TDR in partnership with FIND, and has been guided by a Steering Committee and technical consultations from 2003 to 2011 overseeing the development of standard operating procedures (SOPs) for the programme (16 ). A network of specimen collection sites was established to contribute specimens to a global bank at the CDC and to facilitate local quality control activities (Figure 2). The report of the first and second rounds of Product Testing was released in 2009 and 2010, respectively (3). This third report adds performance data on 27 new products and 23 re-submitted RDTs. Testing for Round 3 was conducted against an evaluation panel with similar characteristics in terms of overall antigen concentration, parasite origin, and parasite-negative blood samples, to previous panels. The majority of panel samples were retained from previous rounds. The results should be considered together with those from Round 1 and Round 2 (3, 4). 4. objectiVe Evaluate malaria RDTs to produce performance data to guide procurement of RDTs for use in the field in malaria-endemic countries. Figure 2: Network of specimen collection, characterization and testing sites Countries or areas where malaria transmission occurs Countries or areas with limited risk of malaria transmission No malaria Malaria, countries or areas at risk of transm ssion, 2009 This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity. Source: © WHO 2010. All rights reserved. Collection and testing site Specimen characterization Global specimen bank QIMR UCAD KEMRI EHNRI CDC HTD CIDEIM IMT IHRDC IPM DRM IPCIPB RITM UL Abbreviations: CDC Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM Centro Internacional de Entrenamiento y Investigaciones Médicas (Cali, Colombia); DMR Experimental Medicine Research Division (Department of Medical Research, Yangon, Myanmar); EHNRI Ethiopian Health and Nutrition Research Institute (Addis Ababa, Ethiopia); HTD Hospital for Tropical Diseases (London, United Kingdom of Great Britain and Ireland); IHRDC Ifakara Health Research and Development Center (Bagamoyo, The United Republic of Tanzania); IMT Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB Institut Pasteur de Bangui (Bangui, Central African Republic); IPC Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM Institut Pasteur de Madagascar (Antananarivo, Madagascar); KEMRI: Kenya Medical Research Institute (Kisumu, Kenya); QIMR Queensland Institute of Medical Research (Brisbane, Australia); RITM Research Institute of Tropical Medicine (Manila, The Philippines); UCAD: Université Cheikh Anta DIOP (Dakar, Senegal); UL University of Lagos (Lagos, Nigeria). M e tH o d s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 17 5. Materials and MetHods 5.1. test selection In October 2009, the WHO-FIND Malaria RDT Evaluation Programme issued a call for expression of interest to manu- facturers of malaria RDTs along with information regarding the requirements for submission of a product to Round 3 of the Product Testing Programme and the conditions for participation in the Evaluation Programme.14 Requirements included: ISO 13485:2003 certification, supply of sufficient quantities of products (1100 tests from each of 2 lots), compliance with the product definition15 and deadlines for document submission. Twenty three manufacturers, including 62 products, responded to the call. In order to keep to schedule and budget, manufacturers were asked to limit their product submissions to two. The final number of products included in Round 3 was 50. Based on catalogue numbers and verification with manufacturers, 23 of the 50 products (46%) were previously submitted to either Round 1 or Round 2 (Table S3). After 14 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_ testing_round3.htm 15 Working definition of a product can be found here on page 13: http:// www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/ web3_QARDTreport.pdf (accessed 8 September 2011) initial evaluation against the P. falciparum culture-derived panel (Phase 1), all products met minimum performance requirements16 and proceeded to the full evaluation. In summary, of the 50 products fully evaluated: 15 are designed to detect P. falciparum alone, 32 to detect and differentiate P. falciparum from non-P. falciparum malaria, and 3 to detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Annexes 1 and 2 provide a comprehensive overview of product characteristics. 5.2. outline of the product testing protocol The testing process is outlined in Figure 3 and in the Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests - Version 3 (16). In brief, RDTs from each of two lots of each product were evaluated against a panel of parasite-positive and parasite-negative cryo-preserved blood samples, and a panel of parasite-negative samples. Both lots were also tested for heat (thermal) stability, evaluated before and after two months’ storage at 4°C, 35°C and 45°C. Finally, an ease-of-use description was developed using a standard assessment format . The testing process and all results were overseen by the WHO-FIND Malaria RDT Evaluation Programme Committee, and manufacturers were given 60 days to comment on individual product results prior to publication. 16 PDS > 80% against high density (2000p/µl) P. falciparum culture samples Figure 3: Malaria RDT Product Testing Overview PANEL DETECTION SCORE AND FALSE POSITIVE RATE Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)18 Table 1: Manufacturers and products accepted into Round 3 of WHO Malaria RDT Product Testing Programme Manufacturer Product Name Catalogue Numbera Target antigen(s) ABON Biopharm (Hangzhou) Co. Ltdb ABON Malaria Pan/P.f. Rapid Test Device (Whole Blood) IMA-B402 HRP2 aldolase Access Bio, Inc. CareStart ™Malaria pLDH 3 Line Test G0121 pan pLDH pf pLDH CareStart™ Malaria/Pregnancy Combo (pLDH/ HRP2/HCG) G0221 HRP2 pan pLDH HCG CareStart™ Malaria Screen G0231 Pf HRP2/Pf pLDH pan pLDH ACON Biotech (Hangzhou) Co. Ltdb Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402 HRP2 aldolase AZOG,Inc Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 pan pLDH pf pLDH Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V pv pLDH HRP2 Malaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Device MFV-124R c pan pLDH HRP2 Bioland, Ltd Nano Sign Malaria Pf Ag RMAF10 HRP2 NanoSign Malaria Pf/Pan Ag RMAP10 HRP2 pan pLDH NanoSign Malaria Pf/Pv Ag RMAD10 pan pLDH pf pLDH BioNote,Inc. BIONOTE MALARIA P.f&P.v Ag Rapid Test Kit RG19-12 HRP2 pv pLDH BIONOTE MALARIA P.f&Pan Ag Rapid Test Kit RG19-08 HRP2 pan pLDH BIONOTE MALARIA P.f Ag Rapid Test Kit RG19-11 HRP2 Biosynex IMMUNOQUICK CONTACT falciparum 0519K25 HRP2 IMMUNOQUICK CONTACT MALARIA +4 0525K25 HRP2 pan pLDH Blue Cross Bio-Medical (Beijing) Co., Ltd. One Step Malaria P.F Test (cassette) 522352 c HRP2 Core Diagnostics Core™ Malaria Pf MAL-190020 HRP2 Core™ Malaria Pv/Pf Mal-190022 HRP2 pv pLDH Core™ Malaria Pan/Pv/Pf Mal-190026 HRP2 pan pLDH Pv pLDH CTK Biotech, Inc. OnSite Pf Ag Rapid Test R0114Cc HRP2 OnSite Pf/Pan Malaria Ag Rapid Test R0113Cc HRP2 pan pLDH OnSite Malaria Pf/Pv Ag Rapid Test R0112Cc HRP2 Pv pLDH DiaMed - A Division of Bio-Rad OptiMAL-IT 710024c Pan pLDH Pf pLDH Dima • Gesellschaft für Diagnostika mbH Malaria Pan test MAL-W23N-001 HRP2 aldolase ICT Diagnostics ICT Diagnostics Malaria Combo ML02c HRP2 aldolase ICT Diagnostics Malaria Dual ML03 HRP2 pan pLDH ICT Diagnostics Malaria P.f ML01c HRP2 InTec Products, Inc. Advanced Quality™ One Step Malaria P.f/P.v Tri-line Test ITP11003 TC40 HRP2 pv pLDH Advanced Quality™ One Step Malaria P.f Test ITP11002 TC40c HRP2 J. Mitra & Co. Pvt. Ltd. Advantage Malaria Card IR211025 HRP2 Pv pLDH Orchid Biomedical Systems Paracheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3) 30301025 c HRP2 Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver. 3) 30302025 c HRP2 Orgenics Ltd.b Clearview® Malaria pLDH 70884025 pan pLDH Standard Diagnostics Inc.b SD BIOLINE Malaria Ag 05FK40c pan pLDH pf pLDH SD BIOLINE Malaria Ag P.f/Pan 05FK60c HRP2 pan pLDH SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK90 HRP2 Pf pLDH Span Diagnotics Ltd. ParaHIT® - f (Device) 55IC102-10c HRP2 ParaHIT® - f (Dipstick) 55IC101-10c HRP2 SSA Diagnostics & Biotech Systems diagnosticks MALARIA (Pan) Cassette MPNWBC1007.3 pan pLDH diagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.4 HRP2 pan pLDH diagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.5 HRP2 pan pLDH Pv pLDH Vision Biotech (Pty) Ltd.b Clearview® Malaria Combo VB11c HRP2 aldolase Clearview® Malaria Pf VB01c HRP2 Clearview® Malaria Dual Test Device VB20c HRP2 pan pLDH Guangzhou Wondfo Biotech Co. Ltd. One Step Malaria P.f./Pan Whole Blood Test W56-Cc HRP2 pan pLDH One Step Malaria P.f Test W37-Cc HRP2 Zephyr Biomedical Systems Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025c HRP2 aldolase Parabank™ Device - Rapid test for Malaria Pan 50301025c pan pLDH Parascreen™ Device -Rapid test for Malaria Pan/Pf 50310025c HRP2 pan pLDH a Some products may include different catalogue numbers for different box sizes, contact manufacturers for details. b Since enrolment in WHO Malaria Product Testing Round 3, these have become Alere ™ companies. c These products have also been submitted to previous rounds of WHO Malaria RDT Product Testing (Round 1 or 2). For details on all product resubmissions see Table S3. M e tH o d s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 19 5.3. evaluation panels RDTs were evaluated against three panels, specifically: i) P. falciparum culture lines (includes a subset, ‘manufac- turer’s panel’) at low (200 parasites/µl) and high parasite densities (2000 parasites/µl). ii) Wild-type Plasmodium species (P. falciparum, P. vivax) from naturally infected humans and parasite-negative samples at low (200 parasites/µl) and high parasite densities (2000 (or 500017) parasites/µl). All samples are prepared from isolates that express HRP2. iii) Parasite-negative panel (‘clean’ samples and disease- specific or blood factor-specific samples). An overview of the sample collection and characterization process can be found in the methods manuals developed for this purpose (16-17). Characterization results can be found on the WHO/WPRO RDT and FIND websites18 In summary, each panel specimen was characterized for: i) Species by duplicate microscopy (two microscopists) and confirmation by nested PCR of mono-species infection ii) Antigen concentration, determined by quantitative ELISA for HRP2, pLDH, aldolase iii) PCR for malaria and confirmatory testing for other pathology in the case of parasite-negative samples Most samples in the global specimen bank are also character- ized according to HRP2 sequence by PCR amplification. This is no longer performed on samples collected after 2009, as 17 8 (8%) of the 99 P. falciparum dilution samples sets were 200 and 5000 parasites/µl and 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl 18 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_ testing_round3.htm - http://www.finddiagnostics.org/ accumulated evidence indicates no significant effect on RDT sensitivity (18). All samples have their geographical origin recorded. panel composition P. falciparum-cultured parasites panel Twenty culture-adapted strains of P. falciparum of varied geographical origin were selected, including 15 strains with type B HRP2 sequence, 3 with Type A, and 2 with Type C HRP2 sequence. All specimens were derived from the culture bank of CDC, and diluted in O+ USA donor blood (16). Wild-type parasite panel The parasite-positive wild-type (clinical) panel consisted of samples from 99 cases of P. falciparum and 35 cases of P. vivax, derived from 11collection sites in Asia, Africa and South America (Figures 2, 4a and 4b). Samples were collected from febrile patients and processed according to standardized methods designed to preserve target antigen concentration (17). After dilutions and cryo- preservation, samples were transferred to the global bank at CDC for further characterization. The distribution of concentration of HRP2, aldolase and pLDH were determined on a larger sample during the first round of product testing in 2008, and a test panel developed for that round that excluded samples with extremes of high or low antigen concentration. Panels for subsequent rounds, including Round 3, have been maintained within these parameters. Negative blood samples The negative panel consisted of ‘clean’ parasite-negative samples from donor-derived blood obtained in banks or from volunteers in non-endemic (USA) and endemic areas (Philippines, Madagascar, Senegal, Nigeria and Kenya), having Figure 4a: Origin of Phase 2 P. falciparum wild type (clinical) samples (n=99) Figure 4b: Origin of Phase 2 P. vivax wild type (clinical) samples (n=35) Ni ge ria Ce nt ra l Af ric an R ep ub lic Un ite d Re pu bl ic o f T an za ni a M ad ag as ca r Co lo m bi a Pe ru Ca m bo di a M ya nm ar Th e P hi lip pi ne s Ke ny a Et hi op ia Co lo m bi a Pe ru Ca m bo di a Th e P hi lip pi ne s Et hi op ia M ad ag as ca r N o. o f sa m pl es N o. o f sa m pl es 0 5 10 15 20 25 0 5 10 15 20 25 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)20 been malaria-negative by microscopy. The panel further contains parasite-negative samples from donors with diseases that may potentially be in the differential diagnoses of malaria, or contain specific blood factors known to be common in the community or known to have the potential to cause false- positive reactions on immunochromatographic tests (Table 2). All negative control samples were confirmed to be free of Plasmodium parasites by PCR amplification. Further details of the culture, wild-type and parasite- negative panels can be found at http://www.wpro.who.int/NR/rdonlyres/62AA6F12-638E- 4C1E-B7CC-10014B2273CA/0/RndThreeProdTestEvalPanel_ Pub.pdf (accessed 13 September,2011) . 5.4. rdt registration The receipt of each shipment of RDTs at the evaluation centre was recorded in a dedicated RDT register. Temperature monitoring devices were offered to manufacturers free of charge, to accompany RDTs shipments to CDC. All RDTs were stored at ≤ 25°C immediately and temperature monitors were labelled with receipt date and forwarded for downloading, when applicable. 5.5. specimen panel registration All panel specimens were assigned unique identification numbers at the collection sites and stored in aliquots of 50µL at -70°C until the time of testing. All data pertaining to specimen identification, storage location and characterization results are stored in a secure, dedicated database. 5.6. test phases The evaluation was divided into two testing phases: Phase 1 - A screening step to allow the selection of RDTs meeting minimal quality requirements. Products from two lots were evaluated against a panel of 20 culture-derived P. falciparum samples at high (2000 parasites/µl) and low (200 parasites/µl) parasite densities. Products not designed to detect P. falciparum were excluded from Phase 1. To move to the full evaluation (Phase 2), a product evaluated in Phase 1 must have achieved an 80% panel detection score (PDS) against the 2000 parasites/µl samples (Figure 6) Phase 2 - Products from two lots were evaluated against a panel of diluted clinical blood samples containing wild-type parasites and a parasite-negative panel, evaluated for heat (thermal) stability, and assessed for ease-of-use. a. The parasite-positive and parasite-negative panel was comprised of 99 P. falciparum, 35 P. vivax at two parasite densities (200 parasites/µl and 2000 (or 5000)19 parasites/µl), and 100 parasite-negative controls. b. Heat stability evaluation: Baseline testing of 15 RDTs from each of two lots against a single culture-derived P. falciparum isolate (Nigeria XII strain, Pf HRP2 sequence type B with 19 Eight (8%) of the 99 P. falciparum dilution samples sets were 200 and 5000 parasites/µl and 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl a typical antigen concentration) at 200 parasites/µl and 5 RDTs from each lot at 2000 parasites/µl, and 4 RDTs from each lot against a negative sample. This procedure was repeated after RDTs were maintained for 60 days at 4°C, 35°C and 45°C at 75% humidity. c. Ease-of-use assessment: After becoming familiar with the test device, technicians jointly described the test for blood safety characteristics, quality of instructions, number of timed steps and total time to result, using a standard reference guide (16). 5.7. performing rapid tests All RDTs were brought to room temperature prior to first use. Desiccant was inspected for colour changes and products were discarded if present. RDTs were labelled with sample identification number, dilution, and the date when test was performed. Performance of rapid tests was in accordance with manufacturer’s instructions, with the exception that blood transfer was carried out by micro-pipette from the sample tube. The result was recorded by a technician at the minimum specified reading time. A second technician re-read the result within 1 hour for internal monitoring purposes and for information for manufacturers. Technicians were rotated, and blinded to sample type and to each other’s results during Phase 2. Annexes 1 and 2 contain a descriptive and illustrated summary of the test characteristics, steps and guide to interpretation of results. 5.8. interpretation of results Results of control and test lines were recorded as negative or positive by each technician. Each test was read against a standard colour chart and the band intensity graded as 0 (no visible band), 1, 2, 3 or 4. If the control line is recorded as absent by either technician, the test is recorded as invalid. Figures 5 and 6 illustrate the testing sequence at low and high parasite densities. Table 2: Characteristics of Plasmodium spp. negative samples Nature of negative samplea No. Clean-negativeb 50 Anti-nuclear antibody positive (sera) 13 Anti-mouse antibody positive (plasma) 3 Rheumatoid factor positive (whole blood and sera) 4 Rapid plasma reagin positive (sera) 9 Chagas' disease antibody positive (plasma) 2 Dengue antibody positive (whole blood sera) 4 Leishmaniasis antibody positive (sera) 5 Schistosomiasis antibody positive (whole blood and sera) 10 a Whole blood, unless otherwise indicated. Sera and plasma samples were reconstituted packed cells b Healthy volunteers with no known current illness or blood abnormality M e tH o d s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 21 6. data ManageMent The receipt of products was hand recorded in an RDT register at the CDC as per Standard Operating Procedures (SOPs). Data associated with specimen collection and characterization was recorded first on hard copy report forms as per the SOPs at the collection sites (Figure 2), HTD (ELISA reporting) and CDC (PCR) and then entered directly into Excel followed by importation into a specially developed database. The results of the product panel testing and heat stability testing conducted at the CDC were recorded on report forms by each technician individually, as per the SOP. These results were double-data entered, and analysed for discrepancies. All source documents and electronic records of study data are maintained in secure storage until the conclusion of the evaluation, data analysis and report publication. Individual product testing reports and accompanying raw data were distributed to manufacturers’ in July 2011, for a 60 days review period prior to publication of the final report. Figure 5: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 200 parasites/µl The first reading was at the minimum time specified by the manufacturer; the second reading was up to one hour latera. A sample is considered detected only if all first test readings, from both lots, are positive ie. Readings a, b, c and d must be positive. Product A c d Reading 1 Reading 1 Reading 2 Reading 2 Lot 2 Test 3 Test 4 a b Reading 1 Reading 1 Reading 2 Reading 2 Lot 1 Test 1 Test 2 Detected if 4 positive first-readings Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4 (excluding negative results). a second reading results are for internal use only Figure 6: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 2000 parasites/µl The first reading was at the minimum time specified by the manufacturer; the second reading was up to one hour latera. A sample is considered detected only if all first test readings, from both lots, are positive ie. Readings a and b must be positive. Product A a Reading 1 Reading 2 Test 1 Lot 1 b Reading 1 Reading 2 Test 2 Lot 2 Detected if 2 positive first-readings Based on positive results of first test reading (2 tests per lot), in each lot, the mean band intensity score =a+b/2 a second reading results are for internal use only Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)22 7. QUalitY assUrance Product testing follows SOPs developed through prior testing experience and are based on recommendations of expert consultations, with minor modifications made on suggestion by the Steering Committee prior to Round 2 (16). The quality of critical steps was controlled, as follows: i) Quality of the malaria RDTs and their use: All RDTs were stored in a controlled environment at ≤ 25°C; the pouch was opened and desiccant checked immediately before use; manufacturer instructions were followed with the exception of use of the blood transfer device provided by the manufacturer (a micropipette was used to ensure correct blood volume). A temperature-monitoring device was offered to be included with the RDTs for shipment to the testing site. Logs were analysed for any temperatures below or above manufacturers recommended storage conditions. ii) Quality and objectivity of the RDT reading results: Results were read in good lighting by trained technicians tested for visual acuity, and doubly entered into the database. Technicians were rotated. Readings of a second technician were used for internal monitoring purposes, and summarized results reviewed in detail and potential discrepancies identi- fied and cross-checked against source laboratory report forms. All wild-type parasite samples were randomized with para- site-negative samples and re-labelled for blinded reading of the RDT results. iii) Quality of the specimen bank samples: SOPs were established for the preparation of all specimen bank samples (17). Culture lines of parasites and wild-type samples were selected taking into account previous evidence and data from specifically conducted studies. All diluted parasite samples were stored and transported at -70°C, and were used only once within 8 hours of thawing. iv) Quality of the product testing site: The Division ofMalaria and Parasitic Diseases, CDC, is one of the major operating components of the Department of Health and Human Services (HHS) of the USA. The laboratory holds Clinical Laboratory Improvement Amendments (CLIA) accreditation and is monitored by internal quality manage- ment systems (QMS) programmes. 8. etHical considerations Each specimen collection site obtained approval from a WHO Research Ethics Review Committee and/or local institutional review board for specimen collection, transport and archiving of blood samples for the purpose of product testing, lot testing and quality assurance procedures. M e tH o d s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 23 9. data analYsis 9.1. Measures of parasite detection: panel detection score and positivity rates Malaria RDTs detect parasite-derived antigen. The relationship of the concentration of antigen available from the blood sample (after lysis of red cells and parasites) to the peripheral parasite density varies highly due to a series of host and parasite factors. In addition, the population frequency of specific factors that can result in false-positive results may vary. Therefore, field sensitivity and specificity of an RDT may change in different epidemiological situations. The evaluation reported here does not predict sensitivity or specificity in a given field situation. It reports comparative detection of target antigens and false-positive rates of RDTs against a standardized panel, in a controlled, repeatable manner. As the panel is developed to be a close approximation of field samples, the comparative detection rates between products are expected to be reflected by similar comparative detection rates in the field. As the panel is designed to include a large number of samples close to the limits of detection of RDTs (200 parasites/µl), the panel is likely to discriminate more clearly than a field trial. It follows that in some settings, such as where parasite density is very high, differences in the panel detection score (PDS) and positivity rates between tests observed against the WHO evaluation panel may not be observed in patient populations, or may be much smaller. Furthermore, where parasite densities are very low, detection rates may be lower than those reported here. Referring to Figure 5, a product must return four positive test results at the manufacturers’ recommended minimum reading time (two from Lot One, two from Lot Two at the initial reading time) when tested against a parasite density of 200 parasites/µl, to contribute to its PDS. When tested against 2000 or 5000 parasites/µl (Figure 6) the product must return two positive tests at the manufacturers’ recommended minimum reading time (one from each lot). Thus, the PDS is a measure of inter-test and inter-lot consistency, as well as the ability to detect antigen. The PDS for P. falciparum indicates an RDT result confirming the presence of P. falciparum, when tested against cultured and wild-type P. falciparum samples, while the non-P. falciparum PDS (P. vivax detection in this Report) indicates Plasmodium-positive/P. falciparum- negative results when tested on wild-type P. vivax samples. The positivity rate is the percentage of all tests of a particular product that returned a positive test result, at the manufac- turers’ recommended minimum reading time, when tested against a P. falciparum or P. vivax sample. 9.2. false-positive results False-positive results are analysed and reported as two separate groups; those that had incorrect species identifica- tion, and those that returned a positive result for samples not containing Plasmodium spp. parasites. Specifically, the false-positive rate is the percentage of all tests of a particular product that returned a positive test result when it shouldn’t have, based on results at the manufacturers recommended minimum reading time. 9.2.1. incorrect species identification A test is considered as returning an incorrect species result if a positive P. falciparum test line appears upon testing against a sample containing non-P. falciparum (P. vivax) parasites. P. falciparum samples resulting in only a visible pan-specific (or non-P. falciparum-specific) test line on combination tests are also considered to be false-positives. 9.2.2. false-positives from plasmodium- negative samples Any test that produces a positive reading to samples with no Plasmodium parasites is considered a false-positive. In Phase 2, parasite-negative samples consist of clean-negative samples and also samples containing other infectious agents (e.g. Dengue, Leishmania, Chagas) and immunological factors (eg. rheumatoid factor, anti-nuclear antibodies, anti-mouse antibodies) (Table 2). 9.3. band intensity All positive tests results were recorded according to the band intensity against a standard reference chart, matched closely to line colour. Based on the first reader results, the distribution of band intensity results is presented as the mean band intensity of positive results. In addition, the intensity was expressed for each possible result (0, 1, 2, 3 or 4)20 as the percentage recorded at that level. 9.4. lot agreement Disagreement between test lots is calculated from the number of samples that returned a positive result on both RDTs tested in that lot against parasite-positive samples at 200 parasites/µl, and on the single RDT from each lot tested against samples at 2000 (or 5000) parasites/µl. Thus, high inter-lot agreement indicates consistency in detecting malaria parasites. Where one test was invalid and the other positive, positive agreement was recorded. 9.5. invalid tests The total number of tests that were deemed invalid during testing of both lots, using samples at 200 parasites/µl and 2000 (or 5000) parasites/µl. 20 A standard intensity comparison chart is used which allows matching to the closest of four common colour variants of labelled antibodies used on RDTs, each at four levels of intensity. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)24 9.6. Heat (thermal) stability The results of heat stability testing are reported as the number of positive tests from two lots returned at each parasite density (maximum score 30 against 200 parasites/µl samples; 10 against 2000 parasites/µl samples)21 and mean band intensity (for positive tests only) at baseline and after lots were stored at 4°C, 35°C and 45°C for two months against one cultured P. falciparum parasite sample at 200 and 2000 parasites/µl. 21 Fifteen tests per lot against 200 parasites/µl samples and 5 tests per lot against 2000 parasites/ µl samples. Invalid results were excluded from analysis. 10. laboratorY VersUs field- based Malaria rdt eValUations Despite the strengths of the product testing programme, the evaluation is not completely analogous to field testing of malaria RDTs. In order to compose a panel that could be reproducibly used to evaluate RDTs, blood samples were diluted, frozen and stored below −70°C. Blood that has undergone a freeze thaw process and is therefore lysed may not have exactly the same characteristics as fresh blood. A further variation from field equivalence is the use of a micro-pipette to supply blood to the RDT device rather than the blood transfer device provided by the manufacturer. This was necessary because blood is collected from a cryo-tube rather than a finger-prick, and the blood transfer devices provided with a particular product can vary. This technique also ensured consistency of testing by reducing the likeli- hood of operator error. All samples in the panel used for the evaluation are prepared from parasites that express HRP2. The results will therefore not be predictive of field trial results involving parasite populations with significant levels of HRP2 deletion (20). Field trials have a place in product selection, particularly in determining which of a short-list of products is most appropriate for the technicians and situation of its intended use by a programme (e.g. ease-of-use characteristics). Such trials should have carefully defined objectives and procedures designed to achieve these. Trials to determine the likely field sensitivity and specificity of a product also have a place, but require large sample sizes and populations with low parasite densities to determine significant differences between well-performing products, they need to be tightly controlled, and are therefore expensive. They do not allow comparison of a large number of products. WHO has produced recommendations on good practice for malaria field trials which should be followed to improve the repeatability and quality of results (19). r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 25 11. resUlts 11.1. summary In Round 3 of the WHO Malaria RDT Product Testing, 50 products were evaluated against P. falciparum culture samples, and all proceeded to evaluation against wild-type samples collected from parasitaemic patients from three continents and a large panel of parasite-negative samples. Heat stability was assessed at temperatures commonly encountered in malaria endemic countries. Thirteen research institutes have been engaged in either sample collection or sample characterization to establish the evaluation panels. Between April 2010 and February 2011 over 60,000 tests were performed at the CDC. The results of the evaluation reveal the following key outcomes: i) The overall range of results including PDS [formerly ‘Detection Rate’], positivity rate, false-positive rates and heat stability, were similar to those reported in Round 1 and Round 2 (3,4) . However, overall P.falciparum and P. vivax PDS mean and median were higher against the low parasite density samples compared to earlier rounds. ii) A number of RDTs demonstrated consistent detection of malaria at low parasite densities (200 parasites/µl), have low false-positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both, adding to the number of available well-performing tests included in Rounds 1 and 2. iii) Performance between products varied widely at low parasite density (200 parasites/µl); however, the majority of products showed a high level of P. falciparum and P. vivax detection at 2000 (or 5000) parasites/µl. iv) P. falciparum tests targeting HRP2 antigen demonstrated the highest PDS for P. falciparum, and had a higher average PDS than tests targeting pLDH, but there was some overlap. v) Several combination tests achieved PDS in the high part of the range for both P. falciparum and P. vivax. vi) Test performance varied between lots of some products. Tables 3 and 4 summarize the performance of malaria RDTs against P. falciparum cultured parasites and blood containing wild-type P. falciparum and P. vivax parasites and Plasmodium spp. negative samples. Data is colour coded according to arbitrary categories, to ease the interpretation of results, and these do not imply limits of acceptable or unacceptable performance. Detailed information pertaining to product testing Phase 1 and Phase 2 results is included in Annex 3 and Annex 4, respectively. A graphical representation of this data follows in Figures 7-15. r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)26 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 27 Ta bl e 3: S um m ar y Ph as e 1 pe rf or m an ce o f 50 m al ar ia R DT s ag ai ns t 20 c ul tu re d P. f al ci pa ru m li ne s at lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or ea (n =2 0) Fa lse p os iti ve n on -P f in fe ct io nb (% ) In va lid r at e (% ) (n =1 20 ) 20 0 pa ra sit es /µ l 20 00 pa ra sit es /µ l 20 0 pa ra sit es /µ l (n =8 0) 20 00 p ar as ite s/ µl (n =4 0) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 95 .0 10 0. 0 N /A N /A 0. 0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 90 .0 10 0. 0 N /A N /A 0. 8 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 95 .0 10 0. 0 N /A N /A 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 10 0. 0 10 0. 0 N /A N /A 0. 8 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 95 .0 10 0. 0 N /A N /A 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 80 .0 10 0. 0 N /A N /A 0. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 85 .0 10 0. 0 N /A N /A 2. 5 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 85 .0 95 .0 N /A N /A 0. 8 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 65 .0 10 0. 0 N /A N /A 0. 0 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 85 .0 10 0. 0 N /A N /A 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 95 .0 10 0. 0 N /A N /A 0. 8 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 10 0. 0 10 0. 0 N /A N /A 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 80 .0 10 0. 0 N /A N /A 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 80 .0 10 0. 0 N /A N /A 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )c 05 FK 90 St an da rd D ia gn os tic s In c. 95 .0 10 0. 0 N /A N /A 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 70 .0 90 .0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 95 .0 10 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 85 .0 10 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 90 .0 10 0. 0 1. 3 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 95 .0 10 0. 0 1. 3 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 80 .0 10 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 85 .0 10 0. 0 0. 0 (7 9) 0. 0 (3 9) 1. 7 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 85 .0 10 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 80 .0 10 0. 0 0. 0 0. 0 (3 9) 0. 8 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 75 .0 10 0. 0 0. 0 (7 9) 0. 0 0. 8 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 65 .0 10 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 85 .0 6. 3 2. 5 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 95 .0 10 0. 0 0. 0 (7 6) 0. 0 (3 6) 6. 7 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 90 .0 10 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 85 .0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 30 .0 10 0. 0 0. 0 (7 9) 0. 0 (3 9) 1. 7 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 90 .0 10 0. 0 0. 0 0. 0 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 35 .0 10 0. 0 22 .5 0. 0 0. 0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 10 0. 0 1. 3 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 95 .0 10 0. 0 0. 0 0. 0 0. 0 r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)26 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 27 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or ea (n =2 0) Fa lse p os iti ve n on -P f in fe ct io nb (% ) In va lid r at e (% ) (n =1 20 ) 20 0 pa ra sit es /µ l 20 00 pa ra sit es /µ l 20 0 pa ra sit es /µ l (n =8 0) 20 00 p ar as ite s/ µl (n =4 0) Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 85 .0 10 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 95 .0 10 0. 0 0. 0 (7 9) 0. 0 0. 8 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 10 0. 0 10 0. 0 0. 0 (7 9) 0. 0 0. 8 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 85 .0 10 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 80 .0 10 0. 0 0. 0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 10 0. 0 95 .0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 10 0. 0 10 0. 0 0. 0 (7 9) 0. 0 0. 8 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) 90 .0 10 0. 0 N /A N /A 0. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 10 0. 0 N /A N /A 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 10 .0 10 0. 0 N /A N /A 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a A sa m pl e is c on si de re d de te ct ed o nl y if al l R DT s fr om b ot h lo ts re ad b y th e fir st te ch ni ci an , a t m in im um s pe ci fie d re ad in g tim e, a re p os iti ve b Pa n or P v lin e on ly p os iti ve in di ca te s a fa ls e po si tiv e no n P. fa lc ip ar um in fe ct io n De te ct io n ra te (% ) ≥9 5 85 -9 4 50 -8 4 < 50 Fa ls e po si tiv e ra te (% ) <2 2- 5 6 -1 0 >1 0 In va lid ra te (% ) <1 % o f t es ts co nd uc te d 1- 2% o f t es ts co nd uc te d 2- 5% o f t es ts co nd uc te d >5 % o f t es ts co nd uc te d Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)28 Ta bl e 4: S um m ar y Ph as e 2 pe rf or m an ce o f 50 m al ar ia R DT s ag ai ns t w ild t yp e (c lin ic al ) P. f al ci pa ru m a nd P . v iv ax s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0a ) pa ra si te d en si ty ( pa ra si te s/ µl ) an d Pl as m od iu m s pp . n eg at iv e sa m pl es Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or eb Fa lse p os iti ve r at es (% ) To ta l f al se po sit iv e ra te se (% ) In va lid ra te (% ) (n =1 20 4) 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Cl ea n ne ga tiv e sa m pl es Pf s am pl es (n =9 9) Pv s am pl es (n =3 5) Pf s am pl es (n =9 9) Pv s am pl es (n =3 5) Pf s am pl es Pv s am pl es Pf s am pl es Pv s am pl es Fa ls e po si tiv e no n Pf in fe ct io nc (n =3 96 ) Fa ls e po si tiv e Pf in fe ct io nd (n =1 60 ) Fa ls e po si tiv e no n Pf in fe ct io nc (n =1 98 ) Fa ls e po si tiv e Pf in fe ct io nd (n =8 0) Fa lse po sit iv e Pl as m od iu m sp p. In fe ct io n (n =2 00 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 93 .9 N /A 10 0. 0 N /A N /A 40 .0 N /A 35 .7 38 .5 0. 1 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 85 .9 N /A 99 .0 N /A N /A 0. 0 N /A 1. 4 2. 0 0. 1 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 83 .8 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 97 .0 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 1. 0 (1 98 ) 0. 3 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 86 .9 N /A 98 .0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 81 .8 N /A 10 0. 0 N /A N /A 3. 6 (1 39 ) N /A 1. 4 4. 0 (1 99 ) 0. 3 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 84 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 3 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 67 .7 N /A 97 .0 N /A N /A 0. 0 N /A 2. 9 1. 0 0. 2 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 60 .6 N /A 98 .0 N /A N /A 0. 7 (1 39 ) N /A 0. 0 0. 0 0. 2 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 85 .9 N /A 10 0. 0 N /A N /A 0. 7 N /A 0. 0 3. 5 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 96 .0 N /A 99 .0 N /A N /A 0. 0 (1 38 ) N /A 1. 5 (6 8) 1. 5 0. 9 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 89 .9 N /A 98 .0 N /A N /A 0. 0 N /A 1. 4 0. 5 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 84 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 0. 0 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 80 .8 N /A 99 .0 N /A N /A 0. 0 N /A 1. 4 2. 5 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )f 05 FK 90 St an da rd D ia gn os tic s In c. 87 .9 N /A 10 0. 0 N /A N /A 0. 0 N /A 0. 0 2. 0 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 69 .7 0. 0 99 .0 62 .9 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 93 .9 88 .6 99 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 3. 0 (1 99 ) 0. 1 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H/ HR P2 /H CG ) G O2 21 Ac ce ss B io , I N C. 83 .8 94 .3 10 0. 0 97 .1 2. 3 1. 4 (1 39 ) 0. 0 (1 94 ) 1. 4 0. 0 0. 2 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 88 .9 91 .4 10 0. 0 10 0. 0 1. 3 0. 7 6. 1 0. 0 0. 5 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 86 .9 88 .6 10 0. 0 10 0. 0 1. 8 2. 1 0. 0 0. 0 2. 5 (1 99 ) 0. 1 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 82 .8 5. 7 10 0. 0 91 .4 0. 0 5. 7 0. 5 5. 7 3. 5 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 69 .7 48 .6 98 .0 94 .3 0. 0 0. 7 (1 39 ) 0. 0 1. 4 1. 0 0. 2 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 98 .0 51 .4 10 0. 0 97 .1 0. 0 (3 94 ) 0. 0 0. 0 0. 0 (6 9) 2. 5 0. 3 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 84 .9 8. 6 98 .0 91 .4 0. 0 3. 6 0. 0 5. 7 2. 5 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 78 .8 60 .0 99 .0 97 .1 0. 5 (3 94 ) 0. 0 0. 0 1. 4 0. 5 (1 99 ) 0. 3 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 75 .8 17 .1 98 .0 94 .3 1. 7 (3 95 ) 5. 1 (1 38 ) 0. 0 0. 0 2. 0 0. 3 M al ar ia P an T es t M AL -W 23 N- 00 1 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 54 .6 0. 0 97 .0 48 .6 2. 8 15 .7 0. 0 17 .1 44 .0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 95 .0 0. 0 10 0. 0 94 .3 0. 0 (3 95 ) 7. 9 8. 1 0. 0 5. 5 (1 99 ) 0. 3 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 2. 0 5. 7 70 .7 97 .1 0. 0 (3 94 ) 0. 0 (1 39 ) 0. 0 0. 0 0. 0 (1 98 ) 0. 4 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 82 .8 57 .1 97 .0 10 0. 0 1. 0 (3 92 ) 0. 7 (1 36 ) 1. 0 (1 94 ) 0. 0 (6 8) 1. 0 (1 95 ) 1. 9 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 77 .8 0. 0 10 0. 0 91 .4 0. 0 2. 9 0. 0 (1 97 ) 2. 9 0. 5 0. 0 r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 29 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pa ne l D et ec tio n Sc or eb Fa lse p os iti ve r at es (% ) To ta l f al se po sit iv e ra te se (% ) In va lid ra te (% ) (n =1 20 4) 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Cl ea n ne ga tiv e sa m pl es Pf s am pl es (n =9 9) Pv s am pl es (n =3 5) Pf s am pl es (n =9 9) Pv s am pl es (n =3 5) Pf s am pl es Pv s am pl es Pf s am pl es Pv s am pl es Fa ls e po si tiv e no n Pf in fe ct io nc (n =3 96 ) Fa ls e po si tiv e Pf in fe ct io nd (n =1 60 ) Fa ls e po si tiv e no n Pf in fe ct io nc (n =1 98 ) Fa ls e po si tiv e Pf in fe ct io nd (n =8 0) Fa lse po sit iv e Pl as m od iu m sp p. In fe ct io n (n =2 00 ) N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 6. 1 8. 6 89 .9 10 0. 0 0. 5 0. 0 (1 39 ) 0. 0 0. 0 0. 0 0. 1 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 37 .4 85 .7 95 .0 10 0. 0 8. 4 (3 83 ) 0. 0 (1 37 ) 0. 0 (1 94 ) 0. 0 (6 8) 4. 1 (1 95 ) 2. 4 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 83 .8 85 .7 10 0. 0 10 0. 0 1. 3 0. 0 0. 0 0. 0 27 .5 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 50 .5 97 .1 96 .0 68 .6 1. 5 0. 0 0. 5 20 .3 (6 9) 2. 0 (1 98 ) 0. 5 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 89 .9 45 .7 97 .0 88 .6 1. 0 (3 94 ) 2. 1 0. 0 (1 97 ) 7. 1 3. 5 (1 99 ) 0. 4 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 92 .9 97 .1 99 .0 10 0. 0 0. 5 (3 94 ) 0. 0 0. 5 0. 0 3. 5 (1 99 ) 0. 3 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 16 .2 97 .1 93 .9 10 0. 0 0. 8 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 83 .8 0. 0 10 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne Te st IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 86 .9 0. 0 10 0. 0 5. 7 15 .7 (3 95 ) 5. 7 8. 1 (1 97 ) 4. 3 18 .5 0. 2 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 77 .8 31 .4 99 .0 10 0. 0 0. 5 0. 7 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 92 .9 97 .1 98 .0 10 0. 0 0. 3 0. 7 1. 5 (1 97 ) 0. 0 4. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 98 .0 60 .0 10 0. 0 97 .1 0. 3 0. 0 0. 0 0. 0 4. 0 0. 1 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 79 .8 0. 0 10 0. 0 20 .0 0. 0 1. 4 0. 0 0. 0 0. 0 (1 99 ) 0. 1 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 84 .9 97 .1 10 0. 0 10 0. 0 5. 3 0. 0 6. 1 0. 0 28 .0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 92 .9 11 .4 99 .0 94 .3 0. 3 (3 91 ) 0. 0 (1 37 ) 0. 0 (1 97 ) 1. 4 3. 5 (1 98 ) 1. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 93 .9 11 .4 99 .0 94 .3 0. 0 (3 89 ) 0. 0 (1 39 ) 0. 0 (1 96 ) 2. 9 (6 9) 4. 0 (1 99 ) 1. 1 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 81 .8 85 .7 99 .0 10 0. 0 N /A N /A N /A N /A 13 .5 0. 5 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 16 .2 54 .3 92 .9 10 0. 0 N /A N /A N /A N /A 0. 0 0. 3 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 17 .2 62 .9 90 .9 10 0. 0 N /A N /A N /A N /A 0. 5 0. 2 Pf : P la sm od iu m fa lc ip ar um - Pv : P la sm od iu m v iv ax - pa n: P la sm od iu m sp ec ie s a 8 (8 % ) o f t he 9 9 P. fa lc ip ar um d ilu tio n sa m pl es s et s w er e 20 0 an d 50 00 p ar as ite s/ µl a nd 2 (6 % ) o f t he 3 5 P. v iv ax d ilu tio n sa m pl e se ts w er e 20 0 an d 50 00 p ar as ite s/ µl b A sa m pl e is c on si de re d de te ct ed o nl y if al l R DT s fr om b ot h lo ts re ad b y th e fir st te ch ni ci an , a t m in im um s pe ci fie d re ad in g tim e, a re p os iti ve c Fo r c om bi na tio n te st s, Pa n or P v lin e, o nl y, po si tiv e in di ca te s a fa ls e po si tiv e no n P. fa lc ip ar um in fe ct io n d Pf li ne p os iti ve in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n e Th e to ta l n um be r o f t im es a p os iti ve re su lt fo r m al ar ia w as g en er at ed w he n it sh ou ld n ot h av e be en f PD S pr es en te d in th e ta bl e is b as ed o n a po si tiv e pf te st li ne (e ith er p f- H RP 2 or p f- pL DH ). P. fa lc ip ar um P DS b as ed o n in di vi du al te st li ne s w as : pf -p LD H (1 7. 2% a t 2 00 p/ µl ; 9 7% a t 2 00 0p /µ l) an d pf -H RP 2 (8 7. 9% a t 2 00 p/ µl ; 1 00 % a t 2 00 0p /µ l) De te ct io n ra te (% ) ≥9 5 85 -9 4 50 -8 4 < 50 Fa ls e po si tiv e ra te (% ) <2 2- 5 6 -1 0 >1 0 In va lid ra te (% ) <1 % o f t es ts co nd uc te d 1- 2% o f t es ts co nd uc te d 2- 5% o f t es ts co nd uc te d >5 % o f t es ts co nd uc te d Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)30 11.2. phase 1 - p. falciparum culture panel The majority (94%) of tests consistently detected ≥ 95% of P. falciparum cultured parasites at high parasite densities (2000 (or 5000) parasites/µl); however, the panel detection score was highly variable (0-100%) at low parasite densities (200 parasites/µl). At low parasite densities, the products with the highest PDS targeted HRP2 (Figure 7). All products had a PDS ≥ 80% on high parasite density samples and therefore, proceeded onto Phase 2. Figure 7: Phase 1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite densities (parasites/µl) according to target antigen type (HRP2 or pLDH) a A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Refer to Table A3.1 for individual panel detection scores for HRP2 and pf-pLDH test lines r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 31 11.3. phase 2 - Wild-type p. falciparum and p. vivax and plasmodium spp. negative samples 11.3.1. p. falciparum detection All 50 products in Round 3 were designed to detect P. falciparum. Compared to the P. falciparum cultured parasite panel, P. falciparum PDS and positivity rates of wild-type samples were generally higher, reflecting the increased antigen content of wild-type samples. As in Phase 1, the majority of tests (45; 90%) had a panel detection score ≥95% of P. falciparum samples at high parasite densities but only 5 tests (10%) had this high a PDS at low parasite density (200 parasites/µl). All of these products targeted HRP2. All fifteen products specific for P. falciparum alone achieved PDS of ≥50% against low parasite density samples (Figure 8). Figure 8: Phase 2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/µl) according to target antigen type (HRP2 or pLDH)b a 8 (8%) of the 99 P. falciparum dilution samples sets were 200 and 5000 parasites/µl and 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl b Phase 2 evaluation panel consisted of 99 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl; c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; d Refer to Table 4 for individual panel detection scores for HRP2 and pf-pLDH test lines Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)32 11.3.2. p. vivax detection Figure 9 illustrates, that of the 35 products designed to detect P. vivax most detected high parasite densities (2000 (or 5000) parasites/µl) consistently, and several achieved a high PDS against 200 parasite/µL samples. However, the overall detection of the low parasite density wild-type P. vivax samples was lower than that for P. falciparum. At low parasite densities (200 parasite/µL ), only seven products (20%) had panel detection scores ≥ 90% and 18 and 12 products had a PDS of ≥50% and ≥ 75%, respectively. (Table 4) Figure 9: Phase 2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000a) parasite densities (parasites/µl) according to target antigen type (aldolase, pLDH)b 2000 (pLDH) 200 (pLDH) 2000 (Aldolase) 200 (Aldolase) a 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl; b Phase 2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax; RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl; c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 33 11.3.3. combined detection of p. falciparum and p. vivax Considering the 32 combination tests, 14 (44%) had a PDS of ≥50% and 8(25%) had a PDS of ≥ 75% for both P. falciparum and P. vivax at the low parasite density (200 parasites/µl) (Table 4). Several performed well at high parasite densities. Two of the three pan-specific only tests had substantially better panel detection scores for P. vivax than P. falciparum, particularly against low parasite density samples. 11.3.4. p. falciparum and p. vivax positivity rate In addition to the PDS, the positivity rate was also measured. This puts aside test and lot differences captured in the PDS and measures the total number of times a test returned a positive result. As expected, positivity rates were higher than PDS but mirrored PDS against wild-type P. falciparum and P. vivax samples (Figures 10 and 11). Figure 10: Phase 2 P. falciparum panel detection score and positivity rate at 200 parasites/µla P an el D et ec ti o n S co re b /P o si ti vi ty r at ec (% ) Positivity rate (pLDH) Panel Detection Score (pLDH) Positivity rate (HRP2) Panel Detection Score (HRP2) a Phase 2 evaluation panel consisted of 99 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl; b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; c the total number of times a test returned a positive result/total number of times tested; d Refer to Table 4 for individual panel detection scores for HRP2 and pf-pLDH test lines Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)34 11.3.5. band intensity Although RDTs are not quantitative, technicians did grade positive results according to a standard colour chart and mean band intensity (for positive results) was calculated (Annex 4 - Tables A4.2, A4.3). There was a positive correlation between panel detection score and band intensity; suggesting that, as expected, strong test bands are interpreted more reliably. Figure 11: Phase 2 P. vivax panel detection score and positivity rate at 200 parasites/µla P an el D et ec ti o n S co re b /P o si ti vi ty r at ec (% ) Positivity rate (pLDH) Panel Detection Score (pLDH) Positivity rate (Aldolase) Panel Detection Score (Aldolase) a Phase 2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax; . RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl; b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive c The total number of times a test returned a positive result/total number of times tested r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 35 11.3.6. false-positive rates Overall false-positive rates were low, with only six tests having rates >10% on clean-negative samples, on any test line (Figures 12, 13). High false-positive rates were seen with some tests against parasite-negative blood with all four immunological blood abnormalities, in the panel including RPR, Rheumatoid factor, anti-DNA antibody and human anti- mouse antibody samples. However, sample sizes were small. For detailed information regarding the blood abnormality or pathogen that generated false-positive results for a specific product refer to Annex 4 (Tables A4.8, A4.9). Importantly, there was no clear trend of higher false-positive rates for tests with higher PDS, indicating that there was not a clear trade-off between sensitivity and specificity of tests at these detection thresholds (Figures 14, 15). Figure 12: Phase 2 P. falciparum (P. falciparum test line) false positive rate against clean negative samplesa a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 50 were clean negatives from healthy volunteers with no known current illness or blood abnormality; b Refer to Table A4.7 for individual false positive rates for HRP2 and pf-pLDH test lines Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)36 Figure 13: Phase 2 Plasmodium spp. (pan or P. vivax test line) false positive rate against clean negativesa a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 50 were clean negatives, from healthy volunteers with no known current illness or blood abnormality Figure 14: Phase 2 P. falciparum false positive ratea versus P. falciparum panel detection scoreb at low (200) parasite density (parasites/µl) F al se p o si tiv e ra te (% ) P. falciparum PDS at 200 parasites/µl a False positive rate is on clean negatives, only b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 37 Figure 15: Phase 2 P. vivax false positive ratea versus P. vivax panel detection scoreb at low (200) parasite density (parasites/µl) F al se p o si tiv e ra te (% ) P. vivax PDS at 200 parasites/µl a False positive rate is on clean negatives, only b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. 12. Heat stabilitY A single P. falciparum culture sample was used as the refer- ence sample for heat stability testing. Variations in baseline performance reflect inter-test variation as the sample at 200 parasites/µl was at the limit of detection of some products. Several products were stable, meaning that they detected a P. falciparum cultured sample the same number of times at baseline and following incubation for two months (75% humidity) at 4°C, 35°C and 45°C. (Table 5). Detailed results are presented in Annex 4 (Tables A4.11-A4.13a) and in Figures 16-23, the results of both lots are combined (maximum score 30; 15 tests per lot against 200 parasites/µl; maximum score 10; 5 tests per lot against 2000 parasites/µl). Overall, products showed greater stability against samples with high (2000 parasites/µl) compared to low (200 parasites/µl) parasite densities, Figures 16, 18, 20, 22 and Figures 17, 19, 21,23, respectively, as small deteriora- tions at these high parasite densities will not be apparent. In several cases products which had base-line positivity less than 100% showed unpredictable variation in positivity rates on subsequent testing after two months, consistent with test lines on the borderline of visibility. Some test lines showed a high degree of stability at 35°C but lost the ability to detect antigen after incubation at 45°C. As in previous rounds, some products showed an improved performance with incubation (Figures 17, 18, 20, 22 23). Overall, the stability of pLDH- detecting test lines was lower than that for HRP2-detecting test lines, but some tests did exhibit good stability of pLDH test lines, indicating heat-stable combination tests. The summary results of heat/thermal stability testing are presented in Table 5. Note that, as a culture-derived P. falciparum sample is used for heat stability testing, it is not possible to provide stability data on test lines that detect only non-P. falciparum parasites. Such data, and confirmatory data on the stability of recent production lots of all tests, should be obtained from manufacturers during product selection processes when procuring RDTs (Annex 5a). Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)38 Ta bl e 5: H ea t st ab ili ty t es tin g re su lt s fo r 50 m al ar ia R DT s on a c ul tu re d P. f al ci pa ru m s am pl e at lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns it y (p ar as it es /µ l) . P os iti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P f lin e) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P an li ne ) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P f lin e) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P an li ne ) 20 0 pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 00 p ar as ite s/ µl Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C N um be r of t es ts p os iti ve ( m ax . 3 0) N um be r of t es ts p os iti ve (m ax . 3 0) N um be r of t es ts p os iti ve (m ax . 1 0) N um be r of t es ts p os iti ve (m ax . 1 0) Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 30 .0 30 .0 26 .0 N /A N /A N /A 10 .0 9. 0 8. 0 N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 30 .0 30 .0 29 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 29 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 19 .0 0. 0 0. 0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 30 .0 28 .0 27 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 29 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 30 .0 29 .0 30 .0 N /A N /A N /A 10 .0 10 .0 9. 0 N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 30 .0 30 .0 17 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )a 05 FK 90 St an da rd D ia gn os tic s In c. 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 30 .0 24 .0 27 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 30 .0 30 .0 29 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 10 .0 10 .0 9. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 30 .0 30 .0 30 .0 30 .0 30 .0 30 .0 10 .0 10 .0 10 .0 10 .0 10 .0 10 .0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 30 .0 30 .0 30 .0 30 .0 30 .0 30 .0 10 .0 10 .0 10 .0 10 .0 10 .0 10 .0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 30 .0 30 .0 28 .0 30 .0 30 .0 28 .0 10 .0 10 .0 10 .0 10 .0 10 .0 10 .0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 9. 0 2. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 30 .0 30 .0 29 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 5. 0 9. 0 2. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 30 .0 30 .0 29 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 10 .0 9. 0 9. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 30 .0 30 .0 29 .0 0. 0 0. 0 0. 0 10 .0 10 .0 9. 0 9. 0 3. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 30 .0 30 .0 28 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 10 .0 8. 0 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 5. 0 5. 0 10 .0 M al ar ia P an T es t M AL -W 23 N- 00 1 Di m a • Ge se lls ch af t f ür D ia gn os tik a m bH 18 .0 10 .0 7. 0 4. 0 16 .0 12 .0 10 .0 10 .0 9. 0 1. 0 6. 0 4. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 0. 0 0. 0 0. 0 r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 39 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P f lin e) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P an li ne ) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P f lin e) Po sit iv e te st r es ul ts f or P. f al ci pa ru m (P an li ne ) 20 0 pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 00 p ar as ite s/ µl Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C Ba se lin e 35 °C 45 °C N um be r of t es ts p os iti ve ( m ax . 3 0) N um be r of t es ts p os iti ve (m ax . 3 0) N um be r of t es ts p os iti ve (m ax . 1 0) N um be r of t es ts p os iti ve (m ax . 1 0) Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d Lo ts 1 a nd 2 c om bi ne d M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 4. 0 1. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 29 .0 30 .0 29 .0 0. 0 0. 0 2. 0 10 .0 10 .0 10 .0 10 .0 10 .0 10 .0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 9. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 14 .0 4. 0 8. 0 0. 0 11 .0 22 .0 10 .0 10 .0 10 .0 7. 0 8. 0 10 .0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 30 .0 30 .0 30 .0 1. 0 20 .0 25 .0 10 .0 10 .0 10 .0 10 .0 10 .0 8. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 10 .0 9. 0 0. 0 10 .0 9. 0 0. 0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 9. 0 10 .0 10 .0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 30 .0 29 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 10 .0 7. 0 9. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 10 .0 8. 0 9. 0 8. 0 2. 0 9. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne Te st IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 29 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 30 .0 29 .0 29 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 30 .0 29 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 30 .0 30 .0 29 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 30 .0 30 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 N /A N /A N /A Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 30 .0 30 .0 30 .0 0. 0 0. 0 0. 0 10 .0 9. 0 10 .0 8. 0 5. 0 7. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 29 .0 30 .0 28 .0 0. 0 0. 0 0. 0 10 .0 10 .0 10 .0 7. 0 0. 0 5. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) N /A N /A N /A 29 .0 28 .0 30 .0 N /A N /A N /A 10 .0 10 .0 10 .0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s N /A N /A N /A 0. 0 0. 0 0. 0 N /A N /A N /A 8. 0 10 .0 8. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s N /A N /A N /A 0. 0 0. 0 0. 0 N /A N /A N /A 9. 0 10 .0 10 .0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Re su lts p re se nt ed in th e ta bl e ar e ba se d on s ta bi lit y of a p f t es t l in e (e ith er p f- H RP 2 or p f- pL DH ). Re su lts b as ed o n st ab ili ty o f i nd iv id ua l t es t l in es o n 20 0p /µ l s am pl es w er e : pf -p LD H (0 /3 0 at b as el in e an d po st 6 0 d in cu ba tio n at 3 5° C, 4 5° C) a nd p f- H RP 2 (3 0/ 30 a t b as el in e an d po st 6 0 d in cu ba tio n at 3 5° C, 4 5° C) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)40 12.1. p. falciparum test lines Figure 16: Heat stability of P. falciparum specific test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation. 0 20 30 10 Baseline 35°C 45°C N o . o f p o si tiv e re su lts fr o m t w o lo ts a a Maximum score is 30 (15 tests x 2 lots); b Refer to Table A4.11 for individual HRP2 and pf-pLDH test line performance Figure 17: Heat stability of P. falciparum specific test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation. 0 8 10 6 4 2 Baseline 35°C 45°C N o . o f p o si tiv e re su lts fr o m t w o lo ts a a Maximum score is 10 (5 tests x 2 lots); b Refer to Table A4.12 for individual HRP2 and pf-pLDH test line performance r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 41 Figure 18: Heat stability of P. falciparum specific test line in combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts f ro m t w o lo ts a 0 10 20 30 Baseline 35°C 45°C a Maximum score is 30 (15 tests x 2 lots) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)42 Figure 19: Heat stability of P. falciparum specific test line in combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts f ro m t w o lo ts a Baseline 35°C 45°C 0 8 10 6 4 2 a Maximum score is 10 (5 tests x 2 lots) r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 43 12.2. pan-specific test lines Figure 20: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts fr o m t w o lo ts a Baseline 35°C 45°C 0 30 20 10 a Maximum score is 30 (15 tests x 2 lots) Figure 21: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts fr o m t w o lo ts a Baseline 35°C 45°C 0 10 8 6 4 2 a Maximum score is 10 (5 tests x 2 lots) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)44 Figure 22: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts f ro m t w o lo ts a 0 20 30 10 Baseline 35°C 45°C a Maximum score is 30 (15 tests x 2 lots) r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 45 Figure 23: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation. N o . o f p o si tiv e re su lts f ro m t w o lo ts a Baseline 35°C 45°C 0 10 8 6 4 2 a Maximum score is 10 (5 tests x 2 lots) 13. ease of Use description After becoming proficient at using a product, two technicians jointly produced an agreed assessment of product usability. The results, which constitute a description of the product with emphasis on aspects considered of importance to ease-of-use in a field setting, are presented in Table 6. It is strongly recommended that ease-of-use and screening for major test anomalies also be assessed during product selection processes when procuring RDTs (Annex 5b). Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)46 Ta bl e 6: E as e of u se d es cr ip tio n of m al ar ia R DT s in cl ud ed in R ou nd 3 : W H O M al ar ia R DT P ro du ct T es tin g Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Bl oo d sa fe ty a In st ru ct io n qu al ity b Co m - bi ne d sc or e (m ax . 5 ) N um be r of t im ed st ep s To ta l tim e to re su lt Bl oo d tr an sf er de vi ce La ng ua ge of in st ru ct io n Ite m s in cl ud ed in p ac ka ge c M ix in g w el ls in vo lv ed Re tr ac t- ab le ne ed le St rip Ex po se d Sc or e (m ax . 3 ) N o di ag ra m Di ag ra m of re su lt Di ag ra m of re su lt & m et ho d Sc or e (m ax . 2 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (n on c ol or c ha ng e) BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 1 N /A 1 2 1 1 2 4 1 20 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h, Fr en ch , Po rt ug ue se , Sp an is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (c ol or -C ha ng e) Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 1 0 1 2 1 0 1 3 1 20 lo op En gl is h Ca ss et te , T ra ns fe r L oo p, B uf fe r, Al co ho l Sw ab s, La nc et s, De si cc an t ( Co lo r- Ch an gi ng ) IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (C ol or -C ha ng in g) IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 1 N /A 1 2 1 1 2 4 1 20 N /A En gl is h Ca ss et te , B uf fe r, De sic ca nt (N on -C ol or C ha ng e) N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 1 0 1 2 1 1 2 4 1 15 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , L an ce t, De si cc an t ( no n Co lo r C ha ng e) On e St ep M al ar ia P .F T es t ( ca ss et te )d 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 1 N /A 1 2 N /A N /A N /A N /A N /A 1 15 N /A na Ca ss et te , B uf fe r, De sic ca nt (N on -C ol or C ha ng e) On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 1 1 1 3 1 1 2 5 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te s, La nc et (r et ra ct ab le N ee dl e) , A lc oh ol S w ab , B uf fe r, De si cc an t (c ol or -c ha ng e) On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 0 N /A 1 1 1 1 2 3 1 30 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia (V er . 3 ) 30 30 10 25 Or ch id B io m ed ic al S ys te m s 1 0 1 2 1 0 1 3 1 20 lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ab , Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia (V er . 3 ) 30 30 20 25 Or ch id B io m ed ic al S ys te m s 1 0 0 1 1 0 1 2 1 20 lo op En gl is h Di ps tic k, T ra ns fe r L oo p, L an ce t, Al co ho l S w ab , Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 1 0 1 2 1 1 2 4 1 30 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, La nc et , A lc oh ol Sw ab s, Bu ff er , D es ic ca nt (N on -C ol or -C ha ng e) Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 1 0 0 1 1 1 2 3 1 30 Ca pi lla ry tu be En gl is h Di ps tic k, Ca pi lla ry T ub es , L an ce t, Al co ho l Sw ab s, Bu ff er , D es ic ca nt (N on -C ol or -C ha ng e) SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )f 05 FK 90 St an da rd D ia gn os tic s In c. 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r D es ic ca nt (N on C ol or C ha ng e) Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) Co . L td . 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r D es ic ca nt (N on C ol or C ha ng e) BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 1 N /A 1 2 1 1 2 4 1 20 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I nc . 1 0 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, Al c. S w ab s, La nc et s, De si cc an t ( no n co lo r C ha ng e) Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I nc . 1 0 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, Al c. S w ab s, La nc et s, De si cc an t ( no n co lo r C ha ng e) Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I nc . 1 0 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, Al c. S w ab s, La nc et s, De si cc an t ( no n co lo r C ha ng e) Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h, Fr en ch , Po rt ug es e, Sp an is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (c ol or -C ha ng e) r es U lt s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 47 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Bl oo d sa fe ty a In st ru ct io n qu al ity b Co m - bi ne d sc or e (m ax . 5 ) N um be r of t im ed st ep s To ta l tim e to re su lt Bl oo d tr an sf er de vi ce La ng ua ge of in st ru ct io n Ite m s in cl ud ed in p ac ka ge c M ix in g w el ls in vo lv ed Re tr ac t- ab le ne ed le St rip Ex po se d Sc or e (m ax . 3 ) N o di ag ra m Di ag ra m of re su lt Di ag ra m of re su lt & m et ho d Sc or e (m ax . 2 ) Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 1 N /A 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (c ol or -C ha ng e) di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch Sy st em s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ap , Bu ff er , D es ic ca nt (N on -c ol or C ha ng e) IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (C ol or -C ha ng in g) IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 1 N /A 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (C ol or -C ha ng in g) IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 1 N /A 1 2 1 1 2 4 1 20 N /A En gl is h Ca ss et te , B uf fe r, De sic ca nt (N on -C ol or C ha ng e) M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , B uf fe r, Tr an sf er P ip et te , D es ic ca nt (N on -C ol or C ha ng e) M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 1 N /A 1 2 1 1 2 4 1 20 N /A En gl is h Ca ss et te , B uf fe r, De si cc an t ( N on c ol or c ha ng e) M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 1 N /A 1 2 1 1 2 4 1 20 N /A En gl is h Ca ss et te , B uf fe r, De si cc an t ( N on c ol or c ha ng e) M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia Pf /P an 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ab , Bu ff er , D es ic ca nt (c ol or -c ha ng e) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 1 0 1 2 1 1 2 4 1 15 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , L an ce t, De si cc an t ( no n Co lo r C ha ng e) N an oS ig n M al ar ia P f/ Pv A g RM AD 10 Bi ol an d, L td 1 0 1 2 1 1 2 4 1 15 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , L an ce t, De si cc an t ( no n Co lo r C ha ng e) On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 1 1 1 3 1 1 2 5 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te s, La nc et (r et ra ct ab le N ee dl e) , A lc oh ol S w ab , B uf fe r, De si cc an t (c ol or -c ha ng e) On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0 N /A 1 1 1 1 2 3 1 30 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of Bi o- Ra d 0 0 1 1 1 0 1 2 4 20 Ca pi lla ry tu be En gl is h, Fr en ch , Po rt ug ue se , Sp an is h ,G er m an , Ita lia n Ca ss et te , C ap ill ar y Tu be s, Bu ff er , A lc oh ol S w ab s, La nc et , D es ic ca nt (N on -C ol or C ha ng e) , C ov er Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia Pa n/ Pf 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ab , Bu ff er , D es ic ca nt (c ol or -c ha ng e) SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 1 0 1 2 1 1 2 4 1 15 Ca pi lla ry tu be En gl is h, Fr en ch , Po rt ug ue se , Sp an is h Ca ss et te , C ap ill ar y Tu be s, Al co ho l S w ab s, La nc et s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 1 0 1 2 1 1 2 4 1 15 Ca pi lla ry tu be En gl is h, Fr en ch , Po rt ug ue se , Sp an is h Ca ss et te , C ap ill ar y Tu be s, Al co ho l S w ab s, La nc et s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st De vi ce IM A- T4 02 AC ON B io te ch (H an gz ho u) Co . L td . 1 N /A 1 2 1 1 2 4 2 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (n on c ol or c ha ng e) Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 1 N /A 1 2 1 1 2 4 1 15 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te , B uf fe r, De si cc an t (n on c ol or c ha ng e) Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 1 0 1 2 1 1 2 4 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, B uf fe r, La nc et , Al co ho l S w ab , D es ic ca nt (N on -c ol or C ha ng e) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)48 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Bl oo d sa fe ty a In st ru ct io n qu al ity b Co m - bi ne d sc or e (m ax . 5 ) N um be r of t im ed st ep s To ta l tim e to re su lt Bl oo d tr an sf er de vi ce La ng ua ge of in st ru ct io n Ite m s in cl ud ed in p ac ka ge c M ix in g w el ls in vo lv ed Re tr ac t- ab le ne ed le St rip Ex po se d Sc or e (m ax . 3 ) N o di ag ra m Di ag ra m of re su lt Di ag ra m of re su lt & m et ho d Sc or e (m ax . 2 ) BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 1 N /A 1 2 1 1 2 4 1 20 Ca pi lla ry tu be En gl is h Ca ss et te , C ap ill ar y Tu be s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, B uf fe r, Al co ho l Sw ab s, La nc et s, De si cc an t ( Co lo r- Ch an gi ng ) M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 1 N /A 1 2 1 1 2 4 1 20 N /A En gl is h Ca ss et te , B uf fe r, De sic ca nt (N on c ol or c ha ng e) On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 0 N /A 1 1 1 1 2 3 1 30 Pi pe tt e En gl is h Ca ss et te , T ra ns fe r P ip et te s, Bu ff er , D es ic ca nt (N on -C ol or C ha ng e) Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, B uf fe r, Al co ho l Sw ab s, La nc et s, De si cc an t ( Co lo r- Ch an gi ng ) di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch Sy st em s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ap , Bu ff er , D es ic ca nt (N on -c ol or C ha ng e) Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . 1 N /A 1 2 1 1 2 4 1 20 Pi pe tt e En gl is h Ca ss et te , B uf fe r, Tr an sf er P ip et te , D es ic ca nt (N on -c ol or C ha ng e) di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch Sy st em s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ap , Bu ff er , D es ic ca nt (N on -c ol or C ha ng e) Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 1 0 1 2 1 0 1 3 1 20 Lo op En gl is h Ca ss et te , T ra ns fe r L oo p, L an ce t, Al co ho l S w ab , Bu ff er , D es ic ca nt (c ol or -c ha ng e) Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s N /A - n ot a pp lic ab le a M ix in g w el ls in vo lv ed : Y es =0 ; N o= 1; R et ra ct ab le n ee dl e: Y es =1 ; N o= 0; S tr ip e xp os ed (n ot w ith in c ar d or c as se tt e) : E xp os ed =0 , C ov er ed =1 b N o di ag ra m s= 0; D ia gr am o f t he re su lts =1 ; D ia gr am o f r es ul t a nd m et ho d= 2 c Th es e ar e no t n ec es sa ril y st an da rd k it co nt en ts . P ro cu re rs s ho ul s ve rif y w ith th e m an uf ac tu re rs w ha t m at er ia ls a cc om pa ny te st k its a nd e ns ur e th ey p ro cu re a ll th e re qu ire d ac ce ss or ie s at th e sa m e tim e. d In st ru ct io ns p am ph le t n ot in cl ud ed in th e or ig in al p ac ka gi ng Ta bl e 6 (c on tin ue d) d is cU ss io n Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 49 14. discUssion of keY findings This report describes the performance of many of the available malaria antigen-detecting RDTs manufactured under the ISO 13485:2003 quality standard. Malaria RDTs have the potential to provide a huge step forward in the management of febrile illness in malaria-endemic areas. To be useful in this context, malaria RDTs must have adequate: i. sensitivity, to detect nearly all clinically-significant cases of malaria; ii. specificity, to accurately discriminate non-malarial febrile illness from malaria, to ensure appropriate management and accurate disease monitoring; iii. stability, for accuracy to be maintained after transport and storage in ambient conditions; iv. ease of use and safety, to allow safe and correct prepara- tion, and correct interpretation of results. In order to assist National Malaria Control Programmes and other procurement agencies in the selection of products appropriate to their needs, malaria RDTs were evaluated in terms of these four major requirements. The panel used successfully discriminated between the RDTs evaluated, showing a considerable range of performance. Importantly, a number of products demonstrated a high rate of antigen detection combined with a low false-positive rate and good heat (thermal) stability, attributes essential if they are to be relied on as a basis for malaria treatment decisions in most endemic populations. Deserving special note in Round 3 is the marked improvement in PDS of many products re-submitted for evaluation from previous rounds (Table S1, S3). Against the 200 parasites/µl panels, the mean and median PDS of the 23 re-submitted products rose from 61.3% to 74.7% and 63.1% to 83.8%, respectively for P. falciparum detection. For P. vivax, the mean and median rose from 31.1% to 60.7% and from 30.0% to 62.9%, respectively. The results for re-submitted products in Round 3 replace those of previous rounds. The programme adheres to a working definition of ‘product’ which lays out specific conditions/modifications that denote a change in product. Overall, the mean PDS for Round 3 was higher than previous rounds while, importantly, the mean false positive rate rose from 3.5% and 4.3% in Rounds 1 and 2, respectively, to 5.9%; however, the median fell from 1.8% and 2.0% (Rounds 1 and 2) to 1.0% in Round 3. Overall, this indicates an improvement in test quality associated with the period of the WHO-FIND RDT Evaluation Programme. The principal results in this report are presented in Tables 3 and 4. The tables group the RDTs by type, depending on what they aim to detect, e.g. P. falciparum only, P. falciparum and non-falciparum species, non-P. falciparum species only, or all malaria species without discrimination. Panel detection scores at both high and low parasite concentrations are presented, as are false-positive rates, and the percentage of invalid test results. Tests in each category are listed alphabetically, but the results are colour-coded to assist the reader in quick interpretation of the data. These colour codes are intended to be used to quickly compare performance in the different categories and not as performance cut-offs to guide test selection or procurement. WHO recommendations for procurement should be referred to regarding these criteria22. When choosing an appropriate product, it is important to also review the stability results (Table 5) in the context of the expected conditions of transport and storage of the RDTs in the field. This evaluation is performed against a standardized panel of cultured P. falciparum and frozen blood samples by expe- rienced technicians in a research laboratory, and is not therefore a field evaluation of RDT accuracy in a specific epidemiological context in the hands of intended users. The panel is designed to mimic fresh blood samples from actual cases as closely as possible, while allowing direct comparison of a large number of products simultaneously in a manner that controls for confounding factors and is calibrated to a level likely to discriminate performance differences of various products. In interpreting the results, it is therefore important that the following discussion points are taken into account. 14.1. panel detection score (pds) and its relationship to sensitivity Evaluation of the RDTs against the Phase 2 wild-type parasite panel with parasite densities of 200 parasites/µl (Figures 8, 9) revealed a wide range of frequency and consistency of antigen detection between products, recorded as the “Panel Detection Score” (PDS).23 As expected, testing at higher parasite densities (2000 [or 5000] parasites/µl) results in smaller differences in performance. As two tests each from two different lots were tested at 200 parasites/µl, and as all four results had to be positive for a sample to be considered detected by an RDT, a positive result indicated both the ability of a product to detect the target antigen in the sample, and to do this consistently (both tests from both lots). Parasite densities of around 200 parasites/µl should be detected to ensure high field sensitivity for clinically-significant malaria infection in many malaria-endemic populations (5). The PDS against the panels used in this evaluation is expected to differ from the test sensitivity in a specific clinical setting for five main reasons. i. Performance may vary between lots or batches of the same product. Variability in lot performance is an issue with all diagnostics, and it cannot be guaranteed that the results found here will predict results from subsequent RDT lots. It is important to test lots prior to distribution to the 22 Information note on interim selection criteria for procurement of malaria rapid diagnostic tests (RDTs) (January 2010) http://new.paho. org/hq/dmdocuments/2010/infoRDTinterimcriteria.pdf (accessed 25 September, 2011) 23 In the report of WHO Product Testing: Round 1 the PDS was termed the ‘Detection Rate’(3). Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)50 field, to ensure that expected performance is maintained (Section 15.2). ii. In clinical settings, patients show a wide variety of parasite densities, the range of which will depend on the local epidemiology of the disease. The magnitude of the parasite density in the population tested affects the clinical sensitivity of the test. PDS against the test panel of blood samples diluted to 200 parasites/µl are likely to underestimate the clinical sensitivity of an RDT in areas of high-transmission where symptomatic patients often have much higher parasite densities in their blood. Many tests that showed only moderate detection of the 200 parasites/µl panel may perform well in such settings, as indicated by the better PDS of most prod- ucts against the panel set at 2000 parasites/µl. Importantly, when interpreting Figures S1, S2, 7-9, and the colour coding in Tables 3, 4, the small differences in panel detection scores found among the better- performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensitivity, and other issues such as stability, cost, prior experi- ence and training of the intended users, and ease of use (Annex 5b) and manufacturing capacity may be equally important factors in test selection. Taking into consideration the parasite density of the target populations and the likely field sensitivity of RDTs, it is important to note that, even in areas with high transmission and strong malaria immunity, populations may include individuals with low parasite densities but clinically significant infections (e.g. young children, preg- nant women, those regularly using bed nets, immigrants, and others with reduced immunity). The ability to detect low parasite density infections reliably therefore remains important in these cases. As some countries move towards elimination, population immunity will decrease and it will become increasingly important to use diagnostic tests that detect low parasite densities (i.e. with high PDS against 200 parasites/µl samples). iii. Performance of tests against the challenge panel may sometimes not be predictive of sensitivity in clinical testing where antigen expression by certain parasite populations differs greatly from that in the panel. Specifically, there is evidence that P. falciparum strains in some areas of South America do not express HRP2 antigens due to gene deletions (18, 20). If a significant proportion of parasites in a given area do not express HRP2, it is necessary to use tests detecting other target antigens (eg. pLDH or aldolase in the case of HRP2,3 deletions). The distribution of such strains is currently being mapped. To date, no significant parasite populations with high frequencies of non-expression of target antigens have been recorded outside of South America. iv. The conditions under which RDTs are transported and stored can alter their field sensitivity. The tests used in this evaluation were shipped and stored under conditions intended to safeguard against degradation caused by high temperature or other extreme conditions. If similar precautions are not taken with purchased RDTs, loss of performance could result. Ambient temperatures of storage conditions vary widely in settings where these tests are commonly used, as do temperatures during transport, and requirements for heat stability of a product will therefore differ. Tests should be transported and stored well within the temperature range recommended by the manufacturer, and extremes of temperature avoided. v. Diagnostic sensitivity and specificity are dependent on the quality of preparation and interpretation of the tests. Highly trained individuals performed all the testing in this product evaluation. In clinical settings, malaria RDTs will often be used by health workers with limited training and supervision. Simplicity of design and clearly-interpretable results will have an influence on ensuring that the tech- nical proficiency of a product translates into accurate diagnosis in the field.24 14.2. false-positive rate and specificity False-positive rates are reported here against a panel of clean-negative samples taken from blood donated in low- transmission settings by people without malaria symptoms. In addition, false-positive rates were calculated against a smaller number of samples with specific characteristics that affect the likelihood of a false-positive result from an immuno-diagnostic test (e.g. rheumatoid factor, anti-nuclear antibody), or that may be of significance in a specific popula- tion in malaria-endemic areas (e.g. leishmaniasis, dengue). The importance of these results will vary with the intended area of use. High false-positive rates against samples of blood from dengue patients, for example, may not be a significant factor to consider in regions where dengue does not occur. In view of the small number of samples in each category in this evaluation, the results should be considered primarily as a guide to highlight potential cross-reactions that will require close monitoring if relevant to the target population. In general, it is preferable to procure a product with a low rate of false-positive reactions. In the case of many diagnostic tests, a trade-off must be made between a preference for a high rate of antigen detection (sensitivity) and a low false-positive rate (specificity). The context in which the test will be used will guide the relative importance of these two factors in choosing one product over another. Overall, in this evaluation there was no correlation of lower PDS (loss of sensitivity) associated with low false-positive rates (high specificity). A number of products attained both a high PDS and a low false-positive rate. 14.3. Heat (thermal) stability RDTs in this evaluation were held for two months at 35°C and 45°C and 75% humidity and then retested to evaluate stability at these temperatures. The importance of thermal stability will vary according to the ambient conditions under which a product is expected to be transported and stored. Thus, stability at high temperatures will be vital if an RDT is to be 24 Examples available here: http://www.wpro.who.int/sites/rdt/ using_rdts/training/main.htm (accessed 25 September, 2011); http://www.finddiagnostics.org/programs/malaria/find_activities/ rdt-job-aids/ (accessed 25 September, 2011) d is cU ss io n Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 51 stored at clinic level in a country where ambient temperatures can reach 45°C in the hot season, but less critical in a high- altitude or cooler environment where temperatures rarely rise above 35°C. Many commercially-available RDTs list 30°C as the maximal storage temperature. Higher temperatures were used for this evaluation because it is common for malaria- endemic countries to have maximum ambient temperatures of 35°C or above, although the use of cool storage methods can allow storage and use of products designed for storage below these temperatures. Where transport and storage of RDTs is likely to occur at high ambient temperatures, heat (thermal) stability should be seen as a significant factor in ensuring maintenance of sensitivity. High humidity will accelerate the degradation of malaria RDTs and other lateral flow tests. All the products in this evaluation were packaged in individual envelopes that contain a desiccant and are designed to be moisture-proof. This allows the user to open the envelope of a specific test at the time of use, limiting exposure to high humidity. During the stability testing phase of this evaluation, RDTs were stored at 75% humidity. The packaging should, if in good condition, protect the contents from exposure to high humidity during storage. As such, the stability testing results presented here provide an assessment of both the stability of the RDT and the quality of its packaging. Several products showed high stability at the temperatures and time periods used in this evaluation. In general, pan- specific lines (pLDH) performed less well at baseline and were less stable than HRP2 test lines, but there was overlap between the stability of tests against these targets with three pLDH test lines on combination tests maintaining very good positivity rates on low parasite densities, after two months at 45°C. Though temperature and humidity were held constant in this evaluation, temperatures in the field fluctuate with time of day and season. While two months’ storage at a set temperature cannot accurately predict long-term stability under field conditions, loss of parasite detection over this period indicates a likelihood that significant sensitivity will be lost when similar or higher storage temperatures comprise a significant amount of the storage time, and indicates likeli- hood of a higher susceptibility to degradation during short periods of exposure to much higher temperatures, such as during transport (21, 22). 14.4. ease of use description The sensitivity and specificity of RDT results are dependent on the quality of preparation and interpretation of the test. In general, a simpler format with fewer steps or fewer required extraneous materials is likely to be prepared and interpreted more reliably. Thus, cassette-format RDTs are generally more reliably prepared and interpreted than products in dip-stick format (23). The extra cost involved in such a format may be offset by the advantages of increased accuracy and, in some cases, less additional equipment required to perform them. The method of blood transfer from the patient to the test is important for the safety of the user, and for the accuracy of volume of blood transferred. Devices for blood transfer are supplied with RDTs, and vary widely in design. The perform- ance of blood transfer devices was not formally assessed in this evaluation, as blood was transferred from a tube by a micro-pipette to ensure the manufacturer-specified volume was used. Programmes procuring RDTs should consider the adequacy of the blood transfer device supplied, including previous experience of health workers and the costs and time required for re-training. It may often be appropriate to discuss with manufacturers the possibility of changing the blood transfer device from that normally supplied. Clarity of results is important to test interpretation. A clearly visible (intense) test line is less likely to be overlooked than a line that is barely visible. While reading proficiency and adequate work places should always be ensured, health workers may sometimes have sub-optimal vision or work in conditions of inadequate lighting. The intensity of the line of the test band is closely associated with the PDS achieved by RDTs in this report (Tables A4.2, A4.3). The importance of format and simplicity of test design will depend on the intended end-users. Trained laboratory technicians may handle a complicated procedure more reli- ably than village-level volunteers with limited supervision. In all cases, specific proficiency-based training and adequate supervision should be included in any RDT-based diagnostic programme, and clear instructions should be provided in a language and format appropriate for the end-user (23-25). Annex 5b provides guidance on conducting a field-based ease of use assessment. 14.5. inter-lot variability This testing programme evaluated only two production lots of each product. Malaria RDTs are complex biological products made of components commonly supplied from multiple sources, and subject to various conditions during manufacture that may affect the quality of the final product. All manufacturers entered in this evaluation have current ISO 13485:2003 certification, a standard designed to give assur- ance of consistency of quality of final product, if correctly implemented. The results presented here indicate that inter- lot variability does occur, and WHO strongly recommends that a sample of RDTs from each production lot be tested prior to dissemination to the field to ensure it meets an appropriate standard. This can be facilitated by WHO (Section 15.2). Since inter-test variability also occurs, this will be detected to some extent by routine lot testing. Ensuring manufacturers have good manufacturing standards should minimize the likelihood of inconsistencies due to poor practice in the manu- facturing process. Culture-based panels25 that are subsets of the Phase 1 panel of this evaluation are available as reference standards for manufacturers to set their own lot-release criteria against, and the development of panels based on recombinant antigens is a focus of work by FIND, TDR and WHO. 25 To access these panels, contact Malaria_rdt@who.int, cunninghamj@who.int or info@finddiagnostics.org. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)52 14.6. target antigens and species Malaria RDTs included in this evaluation detect one or more of three parasite antigens (HRP2, pLDH, and aldolase) in various combinations. HRP2 is present only in P. falciparum, whereas aldolase and pLDH are present in all four species and may be used as pan or all-species targets. Some tests use differences in pLDH sequences between species as a means to differentiate P. falciparum from P. vivax and other species. There is considerable overlap in the PDS of products targeting the different antigens in this evaluation. While the products with the highest PDS for P. falciparum targeted HRP2, a number of pLDH-detecting products demonstrated high PDS against P. vivax. The stability of tests targeting these different antigens also overlapped. The choice of RDT should take target antigen into account: HRP2-detecting RDTs should not be used in areas where high rates of HRP2 non-expression occur (18,20). Tests detecting only HRP2 (without pLDH or aldolase lines) will have limited utility where non-falciparum malaria is common. pLDH (and possibly aldolase) RDTs may have further advantages where antigen persistence (common with HRP2) may result in a high false-positive rate in areas where early retesting in the weeks immediately after treatment is common. The required sensitivity of a test may also vary with species; a less sensitive test may be acceptable for detection of P. vivax compared to detection of P. falciparum, as severe outcomes due to missed diagnoses are less likely. Use of a sufficiently sensitive pan-specific test may be appropriate in areas where both P. falciparum and P. vivax occur, if all infections were to be managed initially as a P. falciparum infection with artemisinin-based combination therapy (ACT), but species- specific monitoring data would be lost. Tests with high PDS for both P. falciparum and P. vivax were demonstrated in this and previous rounds of product testing (3, 4). It should be noted that pan-species tests were not evaluated for detection of P. ovale or P. malariae in this evaluation due to lack of sources of suitable mono-species infections of these parasites. 15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field This report provides data to guide malaria control and management programmes in selecting products likely to perform to a high standard in the particular contexts in which the programme operates. The final decision on product selection requires that this data be considered in a systematic way, taking into context the distribution of parasite densities of the target population among whom the tests will be used, and the experience and training of the intended users. Further information should be sought from the manufacturer and other sources. An algorithm to guide this process is given in Annex 5a.26 While malaria RDTs can be applied in a number of settings, the greatest potential for impact on public health is in extension of access to accurate, parasite-based diagnosis of malaria to regions and populations where good quality microscopy- based analysis is impractical to maintain. This makes possible the implementation of recent WHO recommendations on universal parasite-based diagnosis prior to anti-malarial therapy (2). This currently applies to most people at risk of malaria in endemic countries (1). In many settings where RDTs have been introduced, the true rate of parasitaemia has been found to be considerably lower than expected, allowing health systems to reduce wastage of anti-malarial medicines and to focus on the appropriate management of non-malarial causes of fever, including early pneumonia and sepsis. A successful RDT programme must therefore address not just malaria but also the management of other common and severe febrile illnesses that occur locally, in the differential diagnoses of malaria, if the potential full public health impact of an RDT programme is to be achieved. 15.1. beyond procurement Diagnostic tests normally represent the starting point in a health system intervention, and their use presumes that appropriate patient management, based on testing, will follow. Thus, successful introduction of RDTs requires careful planning beyond rational procurement to ensure consistent 26 An interactive guide designed to help short-list test according to individual programme needs, based on the performance of tests in rounds 1, 2 and 3 of the WHO Product Testing Programme can be found at http://www.finddiagnostics.org/programs/malaria/ find_activities/product_testing/ d is cU ss io n Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 53 supplies of all necessary materials (including gloves, sharps disposal containers, and supplies required for further case management), training of end-users, community sensitization, and monitoring of diagnostic quality and results. This extends beyond malaria management to management of other febrile diseases and health service delivery systems, and requires an integrated approach with other health programmes impacting on the management of febrile illness. This report provides information to guide procurement of RDTs within this framework. A number of factors beyond performance characteristics reported here must influence procurement decisions. An example algorithm, including ease of use assessment, is provided to guide these decisions in Annexes 5a, 5b. Details of implementation will vary widely between programmes according to local capacity and needs. Further recommendations on budgeting, planning and implementation can be found in Annex 6. 15.2. lot testing Complementary to the product testing programme, WHO, TDR and FIND currently support laboratories that perform continual quality assurance of RDTs in the form of lot testing. This programme responds to requests from national malaria programmes, manufacturers, and procurement bodies to assess the quality of RDT lots prior to purchase or when they arrive in country, prior to dispersal to the field and clinical use. Testing is performed against parasite-positive and negative panels prepared and characterized in the same way as the panels used in this evaluation. A number of other national institutions have also developed this capacity. Lot-testing reassures countries that the product they have purchased is performing to a high standard before distribution, and helps to ensure that manufacturers produce consistently good lots and improve their products. Countries and/or manufacturers ship between 125-175 RDTs to the regional lot testing centres where they are evaluated against a small panel of parasites at high and low parasite densities and negative samples (Figure 2 - IPC, RITM). They are subsequently incubated at a temperature close to the manufacturer’s specified storage temperature and retested at intervals until their expiry date. Initial results are available after five days and then sent at regular intervals. Details of the protocol can be found in the published methods manual for lot testing (17). National malaria programmes and procuring agencies are encouraged to participate in the lot testing programme. To access lot testing through the WHO-FIND programme, contact: Malaria_rdt@who.int or info@finddiagnostics.org at least 2 weeks before RDTs are ready for shipment. Further information is available at www.wpro.who.int/sites/rdt/who_rdt_evalu- ation/lot_testing.htm, or through www.finddiagnostics.org 16. conclUsions This study adds to the large data set on malaria RDT perform- ance published in 2009 and 2010 after the first and second rounds of evaluations (3, 4). The product testing programme is a landmark in the field of malaria RDT evaluations in terms of the number of products evaluated and its comprehensiveness. New laboratory methods were developed and validated to support parasite characterization and this work generated new findings regarding the variation in antigen content at similar parasite densities and the variation in the structure and expression of HRP proteins. The publication of the WHO Product Testing Round 1 and Round 2 results impacted on the procurement practices of countries and procurement agencies, and this Report of Round 3 will add considerably to the number of well-performing RDTs for which comprehensive performance data is now available, and provides updated data on products that have been re-submitted following product modification. Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)54 17. references 1. World Malaria Report 2010. Geneva, World Health Organization, 2010. 2. Guidelines for the Treatment of Malaria, Second Edition. Geneva, World Health Organization, 2010. 3. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008). Geneva, World Health Organization, 2009. ISBN 978 92 4 1598071 4. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009). Geneva, World Health Organization, 2010. ISBN 978 92 4 159946 75. 5. Parasitological Confirmation of Malaria Diagnosis. Report of a WHO technical consultation Geneva, 6-8 October 2009. Geneva, World Health Organization, 2010. ISBN 978 92 4 159941 2 6. Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva, World Health Organization, 2011. ISBN 9789241501125 7. Kolaczinski, J., et al., Comparison of the OptiMAL rapid antigen test with field microscopy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Ann Trop Med Parasitol, 2004. 98(1): p. 15-20. 8. Richter, J., et al., Co-reactivity of plasmodial histidine- rich protein 2 and aldolase on a combined immuno- chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitol Res, 2004. 94(5): p. 384-5. 9. Huong, N.M., et al., Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Trop Med Int Health, 2002. 7(4): p. 304-8. 10. Mason, D.P., et al., A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop, 2002. 82(1): p. 51-9. 11. Van den Broek, I., et al., Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg, 2006. 75(6): p. 1209-15. 12. McMorrow, M.L., et al., Challenges in routine implementation and quality control of rapid diagnostic tests for malaria--Rufiji District, Tanzania. Am J Trop Med Hyg, 2008. 79(3): p. 385-90. 13. Wanji, S., et al., Performance and usefulness of the Hexagon rapid diagnostic test in children with asymptomatic malaria living in the Mount Cameroon region. Malar J, 2008. 7: p. 89. 14. Willcox, M.L., et al., Rapid diagnostic tests for the home-based management of malaria, in a high- transmission area. Ann Trop Med Parasitol, 2009. 103(1): p. 3-16. 15. Belizario, V.Y., et al., Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections. Southeast Asian J Trop Med Public Health, 2005. 36(3): p. 552-61. 16 WHO-TDR-FIND-CDC. Methods manual for product testing of malaria rapid diagnostic tests (Version Three). Geneva, World Health Organization, 2010. 17. WHO-TDR-FIND. Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests, Version Six. Geneva, World Health Organization, 2010. 18. Baker J, Ho MF, Pelecanos A, Gatton M, Chen N, Abdullah S, Albertini A, Ariey F, Barnwell J, Bell D, et al, Global sequence variation in the histidine-rich proteins 2 and 3 of Plasmodium falciparum: implications for the performance of malaria rapid diagnostic tests. Malar J 2010, 9:129. 19. Methods for Field Trials of Malaria Rapid Diagnostic Tests. Manila, World Health Organization Regional Office for the Western Pacific, 2009. 20. Gamboa, D., M. F. Ho, et al. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One, 2010: 5(1): e8091. 21. Jorgensen, P., et al., Malaria rapid diagnostic tests in tropical climates: The need for a cool chain. American Journal of Tropical Medicine and Hygiene, 2006. 74(5). 22. Chiodini, P.L., et al., The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg, 2007. 101(4): p. 331-7. 23. Rennie, W., et al., Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg, 2007. 101(1): p. 9-18. 24. Harvey, S.A., et al., Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J, 2008. 7(1): p. 160. 25. Tavrow, P., E Knebel, L Cogswell, Using quality design to improve malaria rapid diagnostic tests in Malawi, in Operations Research Results 1(4). 2000, Published for the United States Agency for International Development (USAID) by the Quality Assurance Project (QAP): Bethesda, Maryland. 26. Thiam S, Thior M, Faye B, Ndiop M, Diouf ML, Diouf MB, Diallo I, Fall FB, Ndiaye JL, Albertini A, et al: Major reduction in anti-malarial drug consumption in senegal after nation-wide introduction of malaria rapid diagnostic tests. PLoS One 2011, 6:e18419 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 55 anneXes Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)56 an ne x 1: c ha ra ct er is tic s of r ap id m al ar ia te st s in r ou nd 3 Pl as m od iu m sp ec ie s ta rg et ed (F = P . f al ci pa ru m V = P. v iv ax O = P. o va le M = P . m al ar ia e P = PA N ; m aj or Pl as m od iu m sp ec ie s ) Se qu en ce a nd t yp e of b ou nd a nt ib od yb T1 T2 T3 C Re qu ire d vo lu m e (µ l) of w ho le bl oo d Bu ff er vo lu m e (d ro ps ) M in im um tim e to re su lts c (m in s) M ax i- m um re ad in g tim e (m in s) Re su lts In te rp re - ta tio nd (T yp e A -J ) Fo rm at ty pe e M an uf ac tu re r Pr od uc t na m e Ca ta lo gu e nu m be r Ta rg et a nt ig en a ( s) C T1 T2 T3 AB ON B io ph ar m (H an gz ho u) C o. L td AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e (W ho le B lo od ) IM A- B4 02 F,P al do la se , H RP 2 √ al do la se H RP 2 10 4 15 20 C A Ac ce ss B io , I N C. Ca re St ar t ™ M al ar ia p LD H 3 L in e Te st G 01 21 F,P pa n- pL DH , p f- pL DH √ Pa n pL DH Pf -p LD H 5 2 20 C A Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G 02 21 F,P pa n- pL DH , H RP 2 √ H CG pa n- pL DH H RP 2 5 2 20 Cf A Ca re St ar t™ M al ar ia S cr ee n G 02 31 F,P pa n- pL DH , H RP 2, p f- pL DH √ Pa n pL DH H RP 2/ Pf - pL DH 5 2 20 C A AC ON B io te ch (H an gz ho u) C o. L td Su re st ep ™ M al ar ia P f/ Pa n Ra pi d Te st De vi ce (W ho le B lo od ) IM A- T4 02 F,P al do la se , H RP 2 √ al do la se H RP 2 10 m ul ti- st ep 15 20 C A AZ OG , I nc . M al ar ia p f ( pL DH ) / P AN -p LD H Te st D ev ic e M FV -1 24 F,P pa n- pL DH , p f- pL DH √ pa n- pL DH pf -p LD H 5 2 20 20 C A M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V F,V pv -p LD H , H RP 2 √ pv -p LD H H RP 2 5 2 20 20 E A M al ar ia p f ( H RP II ) / (P AN -L DH ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 2 20 20 C A Bi ol an d, L td N an o Si gn M al ar ia P f A g RM AF 10 F H RP 2 √ H RP 2 5 4 15 20 A A N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 4 15 20 C A N an oS ig n M al ar ia P f/ Pv A g RM AD 10 F,P pa n- pL DH , p f- pL DH √ pa n- pL DH pf -p LD H 5 4 15 20 C A Bi oN ot e, In c. BI ON OT E M AL AR IA P. f& P.v A g Ra pi d Te st K it RG 19 -1 2 F,V pv -p LD H , H RP 2 √ pv -p LD H H RP 2 5 4 20 30 E A BI ON OT E M AL AR IA P. f& Pa n Ag R ap id Te st K it RG 19 -0 8 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 4 20 30 C A BI ON OT E M AL AR IA P .f Ag R ap id T es t K it RG 19 -1 1 F H RP 2 √ H RP 2 5 4 20 30 A A Bi os yn ex IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 F H RP 2 √ H RP 2 15 4 20 20 A A IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 15 4 20 20 C A Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 F H RP 2 √ H RP 2 5 5 15 20 A A Co re D ia gn os tic s Co re ™ M al ar ia P f M AL -1 90 02 0 F H RP 2 √ H RP 2 5 2 20 A A Co re ™ M al ar ia P v/ Pf M al -1 90 02 2 F,V pv -p LD H , H RP 2 √ pv -p LD H H RP 2 5 2 20 E A Co re ™ M al ar ia P an /P v/ Pf M al -1 90 02 6 F,P ,V pa n- pL DH , p v- pL DH , H RP 2 √ pa n- pL DH pv -p LD H H RP 2 5 2 20 G A CT K Bi ot ec h, In c. On Si te P f A g Ra pi d Te st R0 11 4C F H RP 2 √ H RP 2 5 3 30 A A On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C F,P pa n- pL DH , H RP 2 √ H RP 2 pa n- pL DH 5 3 30 D A On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C F,V pv -p LD H , H RP 2 √ H RP 2 pv -p LD H 5 3 30 F A Di aM ed - A D iv is io n of B io -R ad Op tiM AL -I T 71 00 24 F,P pa n- pL DH , p f- pL DH √ pa n- pL DH pf -p LD H 10 m ul ti- st ep C A Di m a • G es el ls ch af t f ür D ia gn os tik a m bH M al ar ia P an te st M AL - W 23 N -0 01 F,P al do la se , H RP 2 √ H RP 2 a ld ol as e 5 4 15 30 D A R & R M ar ke tin g / I CT D ia gn os tic s IC T Di ag no st ic s M al ar ia C om bo M L0 2 F,P al do la se , H RP 2 √ H RP 2 al do la se 5 5 15 D A IC T Di ag no st ic s M al ar ia D ua l M L0 3 F,P pa n- pL DH , H RP 2 √ H RP 2 pa n- pL DH 5 5 20 D A IC T Di ag no st ic s M al ar ia P .f M L0 1 F H RP 2 √ H RP 2 5 5 15 A A In Te c Pr od uc ts , I nc . Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P. f/ P. v Tr i- lin e Te st IT P1 10 03 T C4 0 F,V pv -p LD H , H RP 2 √ pv -p LD H H RP 2 10 3 15 E A A dv an ce d Qu al ity ™ On e S te p M al ar ia P. f T es t IT P1 10 02 T C4 0 F H RP 2 √ H RP 2 10 3 15 A A J. M itr a & C o. P vt . L td .c /o B io m ed In du st rie s Ad va nt ag e M al ar ia C ar d IR 21 10 25 F,V pv -p LD H , H RP 2 √ pv -p LD H H RP 2 5 5 20 E A an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 57 Pl as m od iu m sp ec ie s ta rg et ed (F = P . f al ci pa ru m V = P. v iv ax O = P. o va le M = P . m al ar ia e P = PA N ; m aj or Pl as m od iu m sp ec ie s ) Se qu en ce a nd t yp e of b ou nd a nt ib od yb T1 T2 T3 C Re qu ire d vo lu m e (µ l) of w ho le bl oo d Bu ff er vo lu m e (d ro ps ) M in im um tim e to re su lts c (m in s) M ax i- m um re ad in g tim e (m in s) Re su lts In te rp re - ta tio nd (T yp e A -J ) Fo rm at ty pe e M an uf ac tu re r Pr od uc t na m e Ca ta lo gu e nu m be r Ta rg et a nt ig en a ( s) C T1 T2 T3 Or ch id B io m ed ic al S ys te m s Pa ra ch ec k® P f D ev ic e - Ra pi d te st fo r P . fa lc ip ar um M al ar ia (V er .3 ) 30 30 10 25 F H RP 2 √ H RP 2 5 2 20 A A Pa ra ch ec k® P f D ip st ic k - Ra pi d te st fo r P. fa lc ip ar um M al ar ia (V er . 3 ) 30 30 20 25 F H RP 2 √ H RP 2 5 4 (T es t t ub e) 20 A D Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 P pa n- pL DH √ pa n pL DH 5 4 20 60 B A St an da rd D ia gn os tic s In c. SD B IO LI N E M al ar ia A g 05 FK 40 F,P pa n- pL DH , p f- pL DH √ pa n- pL DH pf -p LD H 5 4 15 30 C A SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 4 15 30 C A SD B IO LI N E M al ar ia A g P. f ( H RP 2/ pL DH ) 05 FK 90 F pf -p LD H , H RP 2 √ pf -p LD H H RP 2 5 4 15 30 J A Sp an D ia gn ot ic s Lt d. Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 10 F H RP 2 √ H RP 2 8 4 30 30 A A Pa ra H IT ® - f ( Di ps tic k) 55 IC 10 1- 10 F H RP 2 √ H RP 2 8 4 (T es t t ub e) 30 30 A D SS A Di ag no st ic s & B io te ch S ys te m s di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 P pa n- pL DH √ pa n- pL DH 5 2 20 B A di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 2 20 C A di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 F,P ,V pa n- pL DH , p v- pL DH , H RP 2 √ pa n- pL DH pv -p LD H H RP 2 5 2 20 G A Vi si on B io te ch (P ty ) L td Cl ea rv ie w ® M al ar ia C om bo VB 11 F,P al do la se , H RP 2 √ H RP 2 al do la se 5 5 15 D A Cl ea rv ie w ® M al ar ia P f VB 01 F H RP 2 √ H RP 2 5 5 15 A A Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 F,P pa n- pL DH , H RP 2 √ H RP 2 pa n- pL DH 5 5 20 D A G ua ng zh ou W on df o Bi ot ec h Co . L td . On e St ep M al ar ia P .f. /P an W ho le B lo od Te st W 56 -C F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 4 15 30 C A On e St ep M al ar ia P .f Te st W 37 -C F H RP 2 √ H RP 2 5 4 15 30 A A Ze ph yr B io m ed ic al S ys te m s M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 F,P al do la se , H RP 2 √ a ld ol as e H RP 2 5 2 20 C A Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 P pa n- pL DH √ pa n- pL DH 5 2 20 B A Pa ra sc re en ™ D ev ic e -R ap id te st fo r M al ar ia P an /P f 50 31 00 25 F,P pa n- pL DH , H RP 2 √ pa n- pL DH H RP 2 5 2 20 C A a pL DH - p la sm od iu m la ct at e de hy dr og re na se ; H RP 2 - hi st id in e ric h pr ot ei n 2; p v - P. vi va x, p f - P .fa lc ip ar um b se qu en ce w he n te st h el d in a h or iz on ta l p os iti on a nd th e sa m pl e w el l i s at th e fa r r ig ht a nd c on tr ol li ne , f ar le ft c Fr om p la ce m en t o f b uf fe r, or fr om ‘i nt er m ed ia te ’ s te p, if a pp lic ab le d Se e An ne x 2 e Fo rm at s in cl ud e: c as se tt e (A ); ca rd (B ); ca ss et te -h yb rid (C ), di ps tic k (D ); or o th er . E ac h pr od uc t s ho ul d id ea lly b e ac co m pa ni ed b y al l r eq ui re d m at er ia ls (l an ce t, pi pe tt e, e tc .) pa rt ic ul ar ly w he n us ed a t t he v ill ag e he al th w or ke r l ev el ; h ow ev er , t hi s is o ft en n ot th e ca se a nd th e co nt en ts de pe nd o n th e re qu es t o f t he p ro cu rin g ag en t. f H CG te st li ne n ot e va lu at ed A Ca ss et te B Ca rd C Ca ss et te h yb rid D Di ps tic k C T S A C T S C T1 T2 C P P f   sa m pl e an d m ix in g w el ls T1C T2 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)58 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 59 annex 2: Malaria rdt guide to results interpretation type a: Malaria generic pf rdt results guide Results Window: C=control line; T=test line with bound HRP-2 or Pf-specific pLDH antibody. C T Negative Results: One line ‘C’ appears in the results window. C T Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even if the test line is faint. C T Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T C T Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)60 type b: Malaria generic Major plasmodium species (pan) rdt results guide Results Window: C=control line; T=test line with bound pan-specific pLDH or aldolase antibody. C T Negative Results: One line ‘C’ appears in the results window. C T Positive Results: Plasmodium species (P. falciparum, P. vivax, P.malariae, P.ovale) infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even is the test line is faint. C T Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T C T an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 61 type c: Malaria generic pan-pf rdt results guide Results Window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2 and/or Pf specific pLDH antibody. C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum: Two lines ‘C’ and ‘T2” appear in the results window. C T1 T2 Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these: Two lines ‘C’ and ‘T1” appear in the results window. C T1 T2 P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)62 type d: Malaria generic pf-pan rdt results guide Results Window: C=control line; T1=test line with bound HRP2 or Pf specific LDH antibody; T2=test line with bound pLDH or aldolase antibody. C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 63 type e: Malaria generic pv-pf rdt results guide Results Window: C=control line; T1=test line with bound P. vivax specific pLDH; T2=test line with bound HRP2 or Pf-specific pLDH antibody. C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)64 type f: Malaria generic pf-pv rdt results guide Results Window: C=control line; T1= test line with bound HRP2 or Pf-specific pLDH antibody; T2=test line with bound P. vivax specific pLDH. C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 65 type g: Malaria generic pan-pv-pf rdt results guide Results Window: C=control line; T1=test line bound with pLDH or aldolase antibody; T2=test line with bound P. vivax specific pLDH; T3=test line with bound HRP2 or Pf-specific pLDH antibody C T2 T3T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 T3 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window. C T1 T2 T3 P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 T3 P. falciparum with or without mixed infection with P. ovale or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window. C T1 T2 T3 P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window. C T1 T2 T3 P. falciparum and P. vivax mixed infection with or without P. ovale and/or P. malariae infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window. C T1 T2 T3 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)66 P. vivax with or without P. ovale and/or P. malariae infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 T3 P. malariae and/or P. ovale P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 T3 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 T3 C T1 T2 T3 C T1 T2 T3 C T1 T2 T3 C T1 T2 T3 C T1 T2 T3 C T1 T2 T3 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 67 type H: Malaria generic VoM1-pf rdt results guide Results Window: C=control line; T1= test line bound with pLDH specific for non. P. falciparum (P. vivax, P. ovale and P. malariae); T2=test line with bound HRP2 or Pf-specific pLDH antibody C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 P. falciparum mixed infection (with anyone or more of P. vivax, P. ovale and P. malariae). Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Non-P. falciparum infection (P. vivax, P. ovale and P. malariae) or mixed infection of these. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 1 VOM -P. vivax, P. ovale, P. malariae Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)68 type i: Malaria generic pv rdt results guide Results Window: C=control line; T=test line bound with P. vivax specific pLDH. C T Negative Results: Only one line ‘C’ appears in the results window. C T Positive Results: P. vivax infection. Two lines ‘C’ and ‘T’ appear in the results window. C T Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T C T an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 69 type j: Malaria generic pf-pf rdt results guide Results Window: C=control line; T1= test line bound with pLDH specific for P. falciparum; T2=test line bound with HRP2. C T2T1 Negative Results: Only one line ‘C’ appears in the results window. C T1 T2 Positive Results: P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window. C T1 T2 P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window. C T1 T2 P. falciparum infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window. C T1 T2 Invalid Results: No ‘C’ line appears in the results window. Repeat the test using a new RDT if no control line appears. C T1 T2 C T1 T2 C T1 T2 C T1 T2 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)70 an ne x 3: p ha se 1 r es ul ts Ta bl eA 3. 1: L ot v ar ia bi lit y in p os iti ve r es ul ts a ag ai ns t Ph as e 1 P. f al ci pa ru m c ul tu re s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns it y (p ar as it es /µ l) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =2 0) To ta l p os iti ve r es ul ts r et ur ne d 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Lo t 1 Lo t 2 Lo t 1 Lo t 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts b (m ax =2 0) Te st 1 Te st 2 N o. p os iti ve ag re em en ts b (m ax =2 0) Te st 1 Te st 2 Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 20 .0 20 .0 20 .0 20 .0 19 .0 19 .0 20 .0 20 .0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 19 .0 18 .0 18 .0 19 .0 18 .0 (1 9) 18 .0 (1 9) 20 .0 20 .0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 20 .0 19 .0 19 .0 19 .0 19 .0 19 .0 20 .0 20 .0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 20 .0 19 .0 (1 9) 19 .0 (1 9) 20 .0 20 .0 20 .0 20 .0 20 .0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 19 .0 19 .0 19 .0 19 .0 19 .0 19 .0 20 .0 20 .0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 19 .0 19 .0 19 .0 16 .0 16 .0 16 .0 20 .0 20 .0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 18 .0 18 .0 17 .0 17 .0 (1 9) 19 .0 17 .0 (1 9) 19 .0 (1 9) 19 .0 (1 9) On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 19 .0 18 .0 18 .0 17 .0 (1 9) 18 .0 17 .0 (1 9) 19 .0 19 .0 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 16 .0 16 .0 14 .0 18 .0 16 .0 16 .0 20 .0 20 .0 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 19 .0 19 .0 18 .0 20 .0 19 .0 19 .0 20 .0 20 .0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 19 .0 20 .0 19 .0 20 .0 19 .0 (1 9) 19 .0 (1 9) 20 .0 20 .0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 19 .0 19 .0 18 .0 18 .0 18 .0 17 .0 20 .0 20 .0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 16 .0 17 .0 16 .0 17 .0 17 .0 17 .0 20 .0 20 .0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. 20 .0 20 .0 20 .0 20 .0 19 .0 19 .0 20 .0 20 .0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 16 .0 15 .0 15 .0 16 .0 16 .0 15 .0 20 .0 18 .0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 20 .0 19 .0 19 .0 20 .0 20 .0 20 .0 20 .0 20 .0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 20 .0 19 .0 19 .0 19 .0 18 .0 18 .0 20 .0 20 .0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 20 .0 18 .0 18 .0 20 .0 20 .0 20 .0 20 .0 20 .0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 20 .0 20 .0 20 .0 20 .0 19 .0 19 .0 20 .0 20 .0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 17 .0 17 .0 17 .0 17 .0 18 .0 16 .0 20 .0 20 .0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 17 .0 (1 9) 18 .0 17 .0 (1 9) 18 .0 18 .0 18 .0 20 .0 19 .0 (1 9) di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 18 .0 18 .0 17 .0 18 .0 19 .0 18 .0 20 .0 20 .0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 19 .0 18 .0 18 .0 20 .0 17 .0 17 .0 20 .0 19 .0 (1 9) IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 18 .0 16 .0 (1 9) 16 .0 (1 9) 17 .0 19 .0 17 .0 20 .0 20 .0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 15 .0 19 .0 15 .0 17 .0 14 .0 14 .0 20 .0 20 .0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 1. 0 1. 0 0. 0 1. 0 0. 0 0. 0 18 .0 19 .0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 19 .0 (1 9) 19 .0 (1 9) 18 .0 (1 8) 19 .0 18 .0 (1 8) 17 .0 (1 8) 18 .0 (1 8) 18 .0 (1 8) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 19 .0 19 .0 19 .0 19 .0 18 .0 18 .0 20 .0 20 .0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 19 .0 17 .0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 8. 0 9. 0 6. 0 11 .0 (1 9) 11 .0 9. 0 (1 9) 19 .0 (1 9) 20 .0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 19 .0 19 .0 18 .0 20 .0 20 .0 20 .0 20 .0 20 .0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 71 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =2 0) To ta l p os iti ve r es ul ts r et ur ne d 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Lo t 1 Lo t 2 Lo t 1 Lo t 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts b (m ax =2 0) Te st 1 Te st 2 N o. p os iti ve ag re em en ts b (m ax =2 0) Te st 1 Te st 2 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 15 .0 15 .0 13 .0 12 .0 13 .0 9. 0 20 .0 20 .0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 1. 0 1. 0 0. 0 1. 0 1. 0 0. 0 20 .0 20 .0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 19 .0 19 .0 19 .0 19 .0 19 .0 19 .0 20 .0 20 .0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 18 .0 18 .0 17 .0 19 .0 17 .0 17 .0 20 .0 20 .0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 20 .0 18 .0 (1 9) 18 .0 (1 9) 19 .0 20 .0 19 .0 20 .0 20 .0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 20 .0 19 .0 (1 9) 19 .0 (1 9) 20 .0 20 .0 20 .0 20 .0 20 .0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 20 .0 19 .0 19 .0 19 .0 19 .0 18 .0 20 .0 20 .0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 20 .0 20 .0 20 .0 17 .0 19 .0 16 .0 20 .0 20 .0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 20 .0 20 .0 20 .0 20 .0 20 .0 20 .0 19 .0 20 .0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 19 .0 (1 9) 20 .0 19 .0 (1 9) 20 .0 20 .0 20 .0 20 .0 20 .0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 18 .0 19 .0 18 .0 19 .0 19 .0 19 .0 20 .0 20 .0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 9. 0 4. 0 2. 0 5. 0 2. 0 20 .0 20 .0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 8. 0 5. 0 3. 0 6. 0 6. 0 4. 0 20 .0 20 .0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Re su lts a re b as ed o n th e fir st re ad er s in te rp re ta tio n ac co rd in g to m an uf ac tu re rs in st ru ct io ns . b N um be r o f s am pl es th at re tu rn ed a p os iti ve re su lt fo r b ot h te st s. W he re o ne te st w as in va lid a nd th e ot he r p os iti ve , p os iti ve a gr ee m en t w as re co rd ed . Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)72 Ta bl e A 3. 2: D is tr ib ut io n of t es t ba nd in te ns it y (0 -4 ) sc or es a ga in st P ha se 1 P . f al ci pa ru m c ul tu re d pa ra si te s at lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity b (n =8 0) Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity b (n =4 0) Pe rc en ta ge d ist rib ut io n of P an te st b an d in te ns ity b (n =8 0) Pe rc en ta ge d ist rib ut io n of P an te st b an d in te ns ity b (n =4 0) 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 1. 3 13 .8 73 .8 11 .3 0. 0 0. 0 0. 0 10 .0 50 .0 40 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 7. 5 10 .0 51 .3 22 .5 8. 8 0. 0 0. 0 2. 5 12 .5 85 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 3. 8 15 .0 42 .5 30 .0 8. 8 0. 0 0. 0 2. 5 12 .5 85 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 0. 0 3. 8 27 .5 42 .5 26 .3 0. 0 0. 0 0. 0 10 .0 90 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 5. 0 20 .0 28 .8 35 .0 11 .3 0. 0 0. 0 2. 5 10 .0 87 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 12 .5 23 .8 45 .0 18 .8 0. 0 0. 0 0. 0 7. 5 27 .5 65 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 10 .0 12 .5 63 .8 11 .3 2. 5 5. 0 2. 5 7. 5 27 .5 57 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ica l ( Be iji ng ) C o. , L td . 10 .0 11 .3 36 .3 33 .8 8. 8 5. 0 0. 0 2. 5 12 .5 80 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 17 .5 48 .8 22 .5 10 .0 1. 3 0. 0 2. 5 7. 5 32 .5 57 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 3. 8 8. 8 65 .0 22 .5 0. 0 0. 0 0. 0 10 .0 42 .5 47 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 2. 5 8. 8 21 .3 45 .0 22 .5 0. 0 0. 0 2. 5 2. 5 95 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 0. 0 12 .5 43 .8 33 .8 10 .0 0. 0 0. 0 2. 5 25 .0 72 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 7. 5 10 .0 57 .5 22 .5 2. 5 0. 0 0. 0 7. 5 15 .0 77 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 16 .3 10 .0 61 .3 12 .5 0. 0 0. 0 0. 0 15 .0 20 .0 65 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )c 05 FK 90 St an da rd D ia gn os tic s In c. 1. 3/ 93 .8 13 .8 /6 .3 18 .8 /0 .0 40 .0 /0 .0 26 .3 /0 .0 0. 0/ 0. 0 0. 0/ 20 .0 0. 0/ 62 .5 7. 5/ 17 .5 92 .5 /0 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 21 .3 21 .3 47 .5 8. 8 1. 3 5. 0 0. 0 12 .5 27 .5 55 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 77 .5 22 .5 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 1. 3 10 .0 25 .0 47 .5 16 .3 0. 0 0. 0 0. 0 12 .5 87 .5 92 .5 7. 5 0. 0 0. 0 0. 0 0. 0 5. 0 95 .0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 5. 0 18 .8 30 .0 35 .0 11 .3 0. 0 0. 0 0. 0 12 .5 87 .5 0. 0 27 .5 52 .5 18 .8 1. 3 0. 0 0. 0 0. 0 7. 5 92 .5 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 2. 5 16 .3 18 .8 40 .0 22 .5 0. 0 0. 0 0. 0 5. 0 95 .0 1. 3 20 .0 43 .8 23 .8 11 .3 0. 0 0. 0 0. 0 2. 5 97 .5 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 1. 3 20 .0 23 .8 37 .5 17 .5 0. 0 0. 0 0. 0 5. 0 95 .0 0. 0 22 .5 48 .8 23 .8 5. 0 0. 0 0. 0 0. 0 2. 5 97 .5 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 13 .8 23 .8 31 .3 17 .5 13 .8 0. 0 0. 0 2. 5 12 .5 85 .0 97 .5 2. 5 0. 0 0. 0 0. 0 2. 5 62 .5 32 .5 2. 5 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 11 .3 22 .5 33 .8 21 .3 11 .3 2. 5 0. 0 7. 5 12 .5 77 .5 91 .3 8. 8 0. 0 0. 0 0. 0 17 .5 32 .5 50 .0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 2. 5 28 .8 41 .3 27 .5 0. 0 0. 0 2. 5 5. 0 92 .5 88 .8 11 .3 0. 0 0. 0 0. 0 5. 0 17 .5 72 .5 5. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 8. 8 22 .5 27 .5 28 .8 12 .5 0. 0 0. 0 2. 5 10 .0 87 .5 98 .8 1. 3 0. 0 0. 0 0. 0 2. 5 62 .5 30 .0 5. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 7. 5 20 .0 37 .5 28 .8 6. 3 2. 5 0. 0 5. 0 25 .0 67 .5 73 .8 26 .3 0. 0 0. 0 0. 0 5. 0 20 .0 72 .5 2. 5 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 12 .5 25 .0 43 .8 15 .0 3. 8 0. 0 0. 0 7. 5 30 .0 62 .5 92 .5 7. 5 0. 0 0. 0 0. 0 0. 0 12 .5 82 .5 5. 0 0. 0 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 18 .8 47 .5 17 .5 15 .0 1. 3 0. 0 0. 0 17 .5 20 .0 62 .5 86 .3 12 .5 1. 3 0. 0 0. 0 52 .5 47 .5 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 12 .5 15 .0 51 .3 21 .3 0. 0 0. 0 0. 0 10 .0 90 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 67 .5 30 .0 2. 5 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 96 .3 3. 8 0. 0 0. 0 0. 0 7. 5 85 .0 7. 5 0. 0 0. 0 92 .5 7. 5 0. 0 0. 0 0. 0 45 .0 55 .0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 1. 3 6. 3 45 .0 37 .5 10 .0 0. 0 0. 0 2. 5 5. 0 92 .5 70 .0 30 .0 0. 0 0. 0 0. 0 10 .0 2. 5 80 .0 7. 5 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 6. 3 18 .8 62 .5 12 .5 0. 0 0. 0 0. 0 10 .0 27 .5 62 .5 10 0. 0 0. 0 0. 0 0. 0 0. 0 92 .5 7. 5 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 10 0. 0 0. 0 0. 0 0. 0 0. 0 10 .0 40 .0 50 .0 0. 0 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 51 .3 27 .5 18 .8 2. 5 0. 0 2. 5 2. 5 22 .5 20 .0 52 .5 97 .5 2. 5 0. 0 0. 0 0. 0 7. 5 52 .5 37 .5 2. 5 0. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 2. 5 16 .3 62 .5 17 .5 1. 3 0. 0 0. 0 10 .0 32 .5 57 .5 91 .3 7. 5 1. 3 0. 0 0. 0 5. 0 15 .0 80 .0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 73 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl 20 0 pa ra sit es /µ l 20 00 p ar as ite s/ µl Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity b (n =8 0) Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity b (n =4 0) Pe rc en ta ge d ist rib ut io n of P an te st b an d in te ns ity b (n =8 0) Pe rc en ta ge d ist rib ut io n of P an te st b an d in te ns ity b (n =4 0) 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 31 .3 65 .0 3. 8 0. 0 0. 0 0. 0 0. 0 17 .5 67 .5 15 .0 8. 8 87 .5 3. 8 0. 0 0. 0 0. 0 0. 0 20 .0 65 .0 15 .0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 1. 3 32 .5 42 .5 23 .8 0. 0 0. 0 0. 0 2. 5 97 .5 77 .5 22 .5 0. 0 0. 0 0. 0 0. 0 7. 5 82 .5 10 .0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 16 .3 13 .8 28 .8 41 .3 0. 0 0. 0 0. 0 5. 0 95 .0 93 .8 6. 3 0. 0 0. 0 0. 0 0. 0 12 .5 67 .5 17 .5 2. 5 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 95 .0 5. 0 0. 0 0. 0 0. 0 0. 0 60 .0 37 .5 2. 5 0. 0 97 .5 2. 5 0. 0 0. 0 0. 0 0. 0 75 .0 25 .0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 5. 0 7. 5 65 .0 18 .8 3. 8 0. 0 0. 0 5. 0 25 .0 70 .0 10 0. 0 0. 0 0. 0 0. 0 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P.v Tr i-L in e Te st IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 0. 0 27 .5 53 .8 17 .5 1. 3 0. 0 0. 0 7. 5 40 .0 52 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 10 .0 11 .3 60 .0 16 .3 2. 5 0. 0 0. 0 7. 5 27 .5 65 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 3. 8 6. 3 28 .8 46 .3 15 .0 0. 0 0. 0 0. 0 15 .0 85 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 0 31 .3 50 .0 18 .8 0. 0 0. 0 0. 0 12 .5 87 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 3. 8 26 .3 33 .8 30 .0 6. 3 0. 0 0. 0 5. 0 12 .5 82 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 5. 0 11 .3 62 .5 17 .5 3. 8 0. 0 0. 0 5. 0 37 .5 57 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 36 .3 43 .8 20 .0 2. 5 0. 0 0. 0 10 .0 87 .5 10 0. 0 0. 0 0. 0 0. 0 0. 0 17 .5 35 .0 47 .5 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 1. 3 3. 8 22 .5 36 .3 36 .3 0. 0 0. 0 0. 0 7. 5 92 .5 97 .5 2. 5 0. 0 0. 0 0. 0 5. 0 50 .0 45 .0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 6. 3 56 .3 37 .5 0. 0 0. 0 0. 0 0. 0 0. 0 57 .5 42 .5 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 73 .8 23 .8 2. 5 0. 0 0. 0 0. 0 20 .0 65 .0 15 .0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 68 .8 27 .5 3. 8 0. 0 0. 0 0. 0 5. 0 67 .5 27 .5 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s N /A : n ot a pp lic ab le a De no te s no b an d vi si bl e b Ca lc ul at io ns in cl ud e in va lid te st s c Re su lts fo r p f- H RP 2 lin e/ pf -p LD H li ne , r es pe ct iv el y Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)74 an ne x 4: p ha se 2 r es ul ts Ta bl eA 4. 1: L ot v ar ia bi lit y in p os iti ve r es ul ts a ga in st P ha se 2 w ild -t yp e P. f al ci pa ru m a nd P . v iv ax s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns it y (p ar as it es /µ l) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =9 9) P. v iv ax s am pl es (n =3 5) To ta l p os iti ve r es ul ts a re tu rn ed To ta l p os iti ve r es ul ts a re tu rn ed 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Lo t 1 Lo t 2 Lo t 1 Lo t 2 Lo t 1 Lo t 2 Lo t 1 Lo t 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =9 9) Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =9 9) Te st 1 Te st 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =4 0) Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =4 0) Te st 1 Te st 2 Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 94 .0 97 .0 94 .0 98 .0 96 .0 95 .0 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 93 .0 93 .0 91 .0 86 .0 .0 (9 8) 86 .0 84 .0 (9 8) 99 .0 98 .0 N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 90 .0 87 .0 84 .0 91 .0 90 .0 87 .0 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 97 .0 97 .0 96 .0 96 .0 (9 8) 97 .0 96 .0 (9 8) 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 89 .0 88 .0 86 .0 92 .0 92 .0 92 .0 97 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 85 .0 86 .0 83 .0 87 .0 84 .0 (9 8) 83 .0 (9 8) 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 92 .0 90 .0 88 .0 91 .0 (9 8) 91 .0 87 .0 (9 8) 98 .0 (9 8) 98 .0 (9 8) N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 86 .0 81 .0 (9 8) 78 .0 (9 8) 80 .0 78 .0 73 .0 96 .0 97 .0 N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 75 .0 76 .0 70 .0 72 .0 72 .0 65 .0 97 .0 (9 8) 98 .0 N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 89 .0 94 .0 88 .0 96 .0 92 .0 90 .0 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 97 .0 95 .0 (9 8) 95 .0 (9 8) 96 .0 (9 8) 96 .0 95 .0 (9 8) 95 .0 (9 5) 98 .0 N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 94 .0 91 .0 89 .0 93 .0 95 .0 92 .0 98 .0 98 .0 N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 87 .0 88 .0 85 .0 93 .0 89 .0 89 .0 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 86 .0 85 .0 83 .0 88 .0 87 .0 83 .0 99 .0 98 .0 N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. 97 .0 96 .0 96 .0 93 .0 90 .0 88 .0 99 .0 99 .0 N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) Co . L td . 79 .0 78 .0 75 .0 79 .0 77 .0 74 .0 99 .0 98 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 24 .0 27 .0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 97 .0 95 .0 95 .0 95 .0 95 .0 94 .0 99 .0 98 .0 34 .0 32 .0 32 .0 33 .0 33 .0 32 .0 35 .0 35 .0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 95 .0 95 .0 94 .0 87 .0 87 .0 83 .0 99 .0 98 .0 (9 8) 35 .0 35 .0 35 .0 35 .0 32 .0 (3 4) 32 .0 (3 4) 34 .0 35 .0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 96 .0 96 .0 96 .0 91 .0 91 .0 88 .0 99 .0 99 .0 35 .0 35 .0 35 .0 34 .0 33 .0 32 .0 35 .0 35 .0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 96 .0 94 .0 93 .0 90 .0 91 .0 86 .0 99 .0 99 .0 34 .0 34 .0 33 .0 35 .0 33 .0 33 .0 35 .0 35 .0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 85 .0 86 .0 84 .0 93 .0 90 .0 87 .0 99 .0 99 .0 10 .0 9. 0 4. 0 11 .0 11 .0 6. 0 32 .0 34 .0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 86 .0 80 .0 78 .0 81 .0 80 .0 74 .0 98 .0 97 .0 27 .0 (3 4) 30 .0 25 .0 (3 4) 28 .0 28 .0 22 .0 34 .0 34 .0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch Sy st em s 99 .0 98 .0 98 .0 97 .0 (9 8) 97 .0 (9 8) 96 .0 (9 7) 99 .0 99 .0 31 .0 28 .0 26 .0 29 .0 26 .0 23 .0 34 .0 (3 4) 34 .0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 90 .0 90 .0 87 .0 93 .0 92 .0 90 .0 98 .0 98 .0 15 .0 14 .0 9. 0 9. 0 12 .0 6. 0 33 .0 33 .0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 81 .0 85 .0 79 .0 87 .0 (9 8) 87 .0 (9 8) 85 .0 (9 7) 98 .0 98 .0 (9 8) 28 .0 30 .0 25 .0 33 .0 33 .0 31 .0 34 .0 35 .0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 80 .0 78 .0 77 .0 79 .0 (9 8) 82 .0 77 .0 (9 8) 98 .0 98 .0 11 .0 15 .0 (3 3) 8. 0 (3 3) 15 .0 13 .0 10 .0 33 .0 34 .0 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 84 .0 82 .0 77 .0 68 .0 66 .0 56 .0 99 .0 96 .0 6. 0 2. 0 1. 0 8. 0 6. 0 1. 0 30 .0 20 .0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 75 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =9 9) P. v iv ax s am pl es (n =3 5) To ta l p os iti ve r es ul ts a re tu rn ed To ta l p os iti ve r es ul ts a re tu rn ed 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Lo t 1 Lo t 2 Lo t 1 Lo t 2 Lo t 1 Lo t 2 Lo t 1 Lo t 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =9 9) Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =9 9) Te st 1 Te st 2 Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =4 0) Te st 1 Te st 2 N o. p os iti ve ag re em en ts c (m ax =4 0) Te st 1 Te st 2 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 97 .0 95 .0 (9 8) 95 .0 (9 8) 98 .0 96 .0 96 .0 99 .0 99 .0 1. 0 0. 0 0. 0 1. 0 1. 0 0. 0 34 .0 34 .0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 8. 0 (9 8) 10 .0 4. 0 (9 8) 7. 0 9. 0 (9 8) 5. 0 (9 8) 77 .0 78 .0 11 .0 14 .0 9. 0 7. 0 6. 0 (3 4) 4. 0 (3 4) 35 .0 34 .0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia Pf /P an 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 96 .0 93 .0 (9 8) 92 .0 (9 8) 86 .0 (9 7) 91 .0 (9 8) 82 .0 (9 6) 95 .0 (9 5) 95 .0 (9 8) 30 .0 (3 4) 33 .0 (3 4) 29 .0 (3 3) 24 .0 (3 3) 24 .0 19 .0 (3 3) 34 .0 (3 4) 34 .0 (3 4) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 87 .0 88 .0 82 .0 88 .0 90 .0 84 .0 99 .0 99 .0 4. 0 3. 0 2. 0 1. 0 1. 0 1. 0 34 .0 33 .0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 13 .0 14 .0 9. 0 9. 0 12 .0 7. 0 92 .0 91 .0 7. 0 7. 0 (3 4) 6. 0 (3 4) 4. 0 6. 0 3. 0 35 .0 35 .0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 49 .0 (9 6) 45 .0 (9 5) 39 .0 (9 3) 58 .0 (9 5) 58 .0 (9 7) 48 .0 (9 3) 91 .0 (9 5) 94 .0 (9 8) 32 .0 (3 4) 32 .0 (3 4) 31 .0 (3 4) 31 .0 (3 4) 34 .0 31 .0 (3 4) 33 .0 (3 3) 35 .0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 90 .0 92 .0 89 .0 88 .0 91 .0 85 .0 99 .0 99 .0 32 .0 32 .0 30 .0 34 .0 34 .0 33 .0 35 .0 35 .0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 68 .0 67 .0 58 .0 61 .0 63 .0 58 .0 96 .0 97 .0 35 .0 35 .0 35 .0 34 .0 35 .0 34 .0 24 .0 31 .0 (3 4) Pa ra sc re en ™ De vi ce - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 99 .0 98 .0 98 .0 92 .0 93 .0 (9 7) 88 .0 (9 7) 99 .0 96 .0 26 .0 27 .0 22 .0 25 .0 27 .0 22 .0 33 .0 32 .0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 96 .0 96 .0 95 .0 94 .0 (9 8) 95 .0 (9 8) 92 .0 (9 7) 99 .0 98 .0 35 .0 35 .0 35 .0 34 .0 35 .0 34 .0 35 .0 35 .0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 25 .0 27 .0 20 .0 31 .0 30 .0 23 .0 97 .0 94 .0 35 .0 35 .0 35 .0 35 .0 34 .0 34 .0 35 .0 35 .0 Su re st ep ™ E as y M al ar ia P f/P an R ap id Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. Lt d. 87 .0 90 .0 87 .0 89 .0 91 .0 87 .0 99 .0 99 .0 3. 0 2. 0 1. 0 2. 0 35 .0 35 .0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 TC 40 In Te c Pr od uc ts , I nc . 92 .0 (9 8) 92 .0 88 .0 (9 8) 96 .0 93 .0 92 .0 99 .0 99 .0 2. 0 0. 0 0. 0 2. 0 1. 0 0. 0 5. 0 3. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 89 .0 86 .0 86 .0 82 .0 81 .0 78 .0 98 .0 99 .0 29 .0 27 .0 25 .0 17 .0 12 .0 11 .0 35 .0 35 .0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 95 .0 96 .0 94 .0 95 .0 94 .0 93 .0 99 .0 97 .0 35 .0 35 .0 35 .0 34 .0 35 .0 34 .0 35 .0 35 .0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 98 .0 99 .0 98 .0 97 .0 98 .0 97 .0 99 .0 99 .0 32 .0 33 .0 32 .0 27 .0 25 .0 21 .0 35 .0 34 .0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 92 .0 92 .0 88 .0 84 .0 82 .0 80 .0 99 .0 99 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 13 .0 16 .0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 91 .0 89 .0 86 .0 92 .0 88 .0 87 .0 99 .0 99 .0 35 .0 35 .0 35 .0 35 .0 34 .0 34 .0 35 .0 35 .0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 96 .0 (9 8) 93 .0 (9 7) 92 .0 (9 6) 96 .0 (9 8) 95 .0 (9 8) 93 .0 (9 7) 98 .0 (9 8) 98 .0 10 .0 8. 0 7. 0 9. 0 (3 4) 7. 0 (3 3) 6. 0 (3 2) 34 .0 34 .0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ics & B io te ch S ys te m s 94 .0 (9 6) 96 .0 (9 7) 92 .0 (9 4) 97 .0 (9 8) 94 .0 (9 8) 92 .0 (9 7) 97 .0 (9 7) 98 .0 12 .0 15 .0 9. 0 9. 0 (3 4) 8. 0 6. 0 (3 4) 34 .0 (3 4) 33 .0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) 90 .0 87 .0 87 .0 89 .0 (9 8) 88 .0 82 .0 (9 8) 98 .0 98 .0 (9 8) 32 .0 30 .0 (3 4) 29 .0 (3 4) 34 .0 35 .0 34 .0 35 .0 34 .0 (3 4) di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch Sy st em s 34 .0 34 .0 28 .0 25 .0 (9 8) 25 .0 18 .0 (9 8) 92 .0 (9 8) 95 .0 30 .0 27 .0 (3 4) 23 .0 (3 4) 26 .0 23 .0 22 .0 35 .0 35 .0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 34 .0 (9 8) 31 .0 23 .0 (9 8) 31 .0 34 .0 22 .0 96 .0 90 .0 (9 8) 28 .0 26 .0 24 .0 32 .0 28 .0 27 .0 35 .0 35 .0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Re su lts a re b as ed o n th e fir st re ad er s in te rp re ta tio n ac co rd in g to m an uf ac tu re rs in st ru ct io ns . b 8 (8 % ) o f t he 9 9 P. fa lc ip ar um d ilu tio n sa m pl es s et s w er e 20 0 an d 50 00 p ar as ite s/ µl a nd 2 (6 % ) o f t he 3 5 P. v iv ax d ilu tio n sa m pl e se ts w er e 20 0 an d 50 00 p ar as ite s/ µl c N um be r o f s am pl es th at re tu rn ed a p os iti ve re su lt fo r b ot h te st s. W he re o ne te st w as in va lid a nd th e ot he r p os iti ve , p os iti ve a gr ee m en t w as re co rd ed . Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)76 Ta bl e A 4. 2: D is tr ib ut io n of t es t ba nd in te ns it y (0 -4 ) sc or es a ga in st P ha se 2 w ild t yp e P. f al ci pa ru m s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity c (n =2 00 ) Pe rc en ta ge d ist rib ut io n of pa n te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of pa n te st b an d in te ns ity c (n =2 00 ) Pe rc en ta ge d ist rib ut io n of P v te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of P v te st b an d in te ns ity c (n =2 00 ) 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P. f T es t IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 2. 8 12 .6 53 .0 20 .2 11 .4 0. 0 1. 0 6. 6 14 .7 77 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 9. 6 14 .4 26 .3 19 .7 30 .1 0. 5 0. 0 2. 5 9. 1 87 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 9. 6 12 .1 25 .3 13 .1 39 .9 0. 0 1. 5 3. 5 3. 5 91 .4 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 2. 3 6. 8 15 .4 22 .2 53 .3 0. 0 0. 0 1. 0 3. 5 95 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 8. 8 13 .6 24 .2 15 .9 37 .4 1. 0 0. 0 2. 0 6. 1 90 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 13 .4 25 .8 28 .0 22 .5 10 .4 0. 0 2. 0 4. 6 15 .2 78 .3 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 8. 1 14 .1 29 .8 17 .2 30 .8 1. 0 0. 0 3. 0 6. 1 89 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 17 .9 18 .2 30 .8 13 .9 19 .2 2. 5 1. 0 4. 6 11 .6 80 .3 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 25 .5 21 .0 29 .3 15 .9 8. 3 1. 5 2. 5 11 .6 16 .2 68 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 6. 3 15 .9 28 .5 34 .3 14 .9 0. 0 0. 0 5. 1 14 .1 80 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al Sy st em s 2. 5 3. 5 14 .4 26 .3 53 .3 0. 5 0. 0 0. 0 4. 0 95 .5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al Sy st em s 5. 8 12 .6 25 .3 29 .6 26 .8 1. 0 0. 5 1. 5 7. 6 89 .4 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 9. 9 17 .9 25 .0 23 .2 24 .0 0. 0 1. 5 2. 5 11 .1 84 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 12 .6 22 .7 29 .3 21 .2 14 .1 0. 5 1. 0 5. 1 16 .7 76 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )d 05 FK 90 St an da rd D ia gn os tic s In c. 5. 1 /6 9. 2 8. 6 /2 3. 2 15 .9 /6 .3 23 .2 /1 .3 47 .2 /0 .0 0. 0 /2 .0 0. 0 /1 0. 6 3. 0 /3 3. 8 3. 5 /3 0. 8 93 .4 /2 2. 7 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t De vi ce IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 21 .0 20 .2 26 .5 16 .7 15 .7 0. 5 2. 0 5. 6 11 .1 80 .8 98 .0 1. 5 0. 5 0. 0 0. 0 40 .4 26 .3 22 .7 7. 6 3. 0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 3. 5 6. 3 15 .2 26 .5 48 .5 0. 5 0. 0 0. 5 4. 0 95 .0 69 .2 25 .8 4. 0 0. 8 0. 3 4. 0 12 .6 31 .3 36 .4 15 .7 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Ca re St ar t™ M al ar ia /P re gn an cy Co m bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 8. 1 13 .1 29 .3 22 .2 27 .3 0. 0 0. 0 3. 5 8. 6 87 .9 9. 6 25 .8 35 .9 21 .5 7. 3 0. 5 0. 0 4. 6 26 .8 68 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 5. 6 10 .6 27 .3 23 .2 33 .3 0. 0 0. 0 1. 0 7. 1 91 .9 8. 6 23 .5 37 .1 22 .2 8. 6 0. 0 0. 0 4. 0 24 .8 71 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 6. 3 9. 1 26 .0 26 .3 32 .3 0. 0 0. 5 4. 6 4. 6 90 .4 9. 1 22 .7 33 .1 23 .7 11 .4 0. 0 0. 5 4. 6 23 .2 71 .7 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 10 .6 10 .4 29 .8 17 .2 32 .1 0. 0 2. 0 4. 0 6. 6 87 .4 74 .8 12 .4 12 .1 0. 8 0. 0 5. 1 16 .7 38 .9 18 .2 21 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 17 .4 10 .4 22 .2 18 .2 31 .8 1. 5 2. 0 2. 0 6. 6 87 .9 78 .3 17 .2 3. 5 1. 0 0. 0 9. 6 16 .2 34 .3 27 .3 12 .6 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & Bi ot ec h Sy st em s 0. 8 5. 6 21 .0 24 .8 48 .0 0. 0 0. 0 1. 0 4. 0 95 .0 74 .2 18 .9 5. 1 1. 5 0. 3 6. 1 14 .1 37 .4 25 .3 17 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 7. 8 12 .4 31 .8 13 .1 34 .9 1. 0 0. 0 3. 5 7. 1 88 .4 76 .8 12 .6 10 .6 0. 0 0. 0 3. 0 13 .6 43 .9 20 .2 19 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 14 .1 12 .9 26 .0 13 .1 33 .8 1. 0 0. 5 3. 5 4. 0 90 .9 71 .7 20 .2 7. 1 0. 5 0. 5 5. 6 14 .1 36 .4 25 .8 18 .2 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M UN OQ UI CK C ON TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 19 .4 21 .5 25 .3 20 .7 13 .1 1. 0 2. 0 4. 0 18 .7 74 .2 72 .2 24 .2 2. 5 1. 0 0. 0 5. 6 24 .2 35 .9 24 .8 9. 6 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 24 .2 24 .8 29 .6 13 .1 8. 3 1. 5 1. 0 14 .1 20 .2 63 .1 72 .2 17 .2 10 .6 0. 0 0. 0 25 .8 31 .3 34 .9 7. 6 0. 5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A M al ar ia p f ( H RP II ) / (P AN -p LD H ) An tig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 2. 5 9. 1 22 .7 24 .2 41 .4 0. 0 0. 0 2. 5 5. 1 92 .4 99 .0 0. 3 0. 8 0. 0 0. 0 41 .9 30 .8 25 .3 1. 5 0. 5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 77 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of P f te st b an d in te ns ity c (n =2 00 ) Pe rc en ta ge d ist rib ut io n of pa n te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of pa n te st b an d in te ns ity c (n =2 00 ) Pe rc en ta ge d ist rib ut io n of P v te st b an d in te ns ity c (n =4 00 ) Pe rc en ta ge d ist rib ut io n of P v te st b an d in te ns ity c (n =2 00 ) 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 M al ar ia p f ( pL DH ) / P AN -p LD H T es t De vi ce M FV -1 24 AZ OG , I nc . 91 .4 7. 6 1. 0 0. 0 0. 0 21 .7 28 .3 39 .4 9. 6 1. 0 98 .7 1. 0 0. 3 0. 0 0. 0 54 .0 25 .8 19 .2 1. 0 0. 0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al Sy st em s 7. 1 5. 8 22 .7 16 .2 48 .2 2. 5 0. 0 1. 0 2. 5 93 .9 57 .8 21 .2 16 .4 3. 5 1. 0 5. 1 4. 0 32 .8 25 .3 32 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 10 .9 12 .6 31 .6 14 .4 30 .6 0. 0 0. 5 4. 0 8. 6 86 .9 98 .7 1. 0 0. 3 0. 0 0. 0 57 .6 24 .2 17 .7 0. 0 0. 5 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 87 .9 10 .1 1. 3 0. 8 0. 0 7. 6 22 .2 41 .9 17 .7 10 .6 99 .2 0. 8 0. 0 0. 0 0. 0 95 .5 4. 6 0. 0 0. 0 0. 0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 47 .0 22 .0 16 .2 7. 8 7. 1 6. 6 6. 1 11 .6 17 .7 58 .1 70 .2 26 .5 2. 5 0. 5 0. 3 12 .1 19 .2 40 .4 18 .2 10 .1 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 8. 8 11 .9 30 .6 31 .1 17 .7 0. 0 0. 0 5. 1 16 .2 78 .8 50 .5 35 .9 12 .4 1. 3 0. 0 2. 0 11 .6 41 .4 34 .3 10 .6 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of Bi o- Ra d 34 .6 37 .1 26 .3 1. 3 0. 8 2. 5 3. 5 24 .8 25 .3 43 .9 35 .1 38 .4 24 .5 1. 3 0. 8 2. 0 3. 0 27 .3 25 .8 41 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al Sy st em s 3. 5 2. 3 20 .7 15 .9 57 .6 1. 5 0. 0 0. 0 1. 5 97 .0 69 .4 20 .7 8. 3 0. 8 0. 8 7. 1 12 .6 37 .4 23 .2 19 .7 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s I nc . 3. 8 8. 6 15 .9 23 .0 48 .7 0. 5 0. 0 0. 5 3. 0 96 .0 56 .1 26 .5 13 .1 3. 8 0. 5 3. 5 3. 0 22 .2 36 .9 34 .3 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s I nc . 71 .5 20 .2 4. 0 1. 5 2. 8 3. 5 11 .6 30 .3 32 .3 22 .2 76 .0 17 .9 4. 8 1. 3 0. 0 3. 5 13 .1 34 .9 32 .8 15 .7 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 9. 9 12 .4 35 .4 22 .7 19 .7 0. 0 0. 0 5. 6 12 .6 81 .8 10 0. 0 0. 0 0. 0 0. 0 0. 0 82 .3 13 .6 4. 0 0. 0 0. 0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P. f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 5. 8 19 .4 47 .0 15 .7 12 .1 0. 0 1. 5 8. 6 14 .7 75 .3 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 84 .3 12 .6 2. 5 0. 5 0. 0 83 .8 13 .1 3. 0 0. 0 0. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 14 .7 11 .6 27 .3 19 .4 27 .0 0. 5 1. 0 4. 6 7. 1 86 .9 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 99 .5 0. 5 0. 0 0. 0 0. 0 99 .5 0. 0 0. 5 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 4. 0 7. 1 18 .2 26 .8 43 .9 1. 0 0. 0 0. 5 3. 5 95 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 99 .8 0. 3 0. 0 0. 0 0. 0 97 .0 0. 5 2. 0 0. 5 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 1. 0 5. 3 12 .6 24 .2 56 .8 0. 0 0. 0 0. 0 3. 0 97 .0 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 99 .8 0. 3 0. 0 0. 0 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) An tig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 11 .6 14 .4 32 .8 16 .4 24 .8 0. 0 1. 0 5. 1 7. 6 86 .4 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 10 0. 0 0. 0 0. 0 0. 0 0. 0 10 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 9. 1 13 .4 29 .3 29 .6 18 .7 0. 0 0. 0 5. 1 15 .2 79 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 94 .7 4. 0 1. 0 0. 3 0. 0 78 .8 12 .6 6. 6 2. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 4. 0 3. 5 15 .9 22 .5 54 .0 0. 5 0. 0 0. 0 3. 5 96 .0 92 .7 4. 3 1. 3 0. 3 1. 5 24 .2 18 .7 31 .3 21 .2 4. 6 10 0. 0 0. 0 0. 0 0. 0 0. 0 99 .5 0. 5 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) Ca ss et te M PN VF C1 00 7. 5 SS A Di ag no st ic s & Bi ot ec h Sy st em s 3. 8 5. 8 14 .4 22 .2 53 .8 1. 5 0. 5 1. 0 2. 0 95 .0 90 .9 6. 1 0. 8 0. 5 1. 8 19 .2 21 .7 34 .3 16 .2 8. 6 10 0. 0 0. 0 0. 0 0. 0 0. 0 99 .0 0. 5 0. 5 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 10 .6 23 .2 36 .4 21 .2 8. 6 0. 5 0. 0 2. 0 13 .6 83 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & Bi ot ec h Sy st em s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 70 .2 18 .9 9. 6 0. 5 0. 8 5. 6 8. 1 33 .8 24 .8 27 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al Sy st em s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A 67 .2 18 .4 12 .4 1. 0 1. 0 6. 1 5. 6 37 .4 19 .2 31 .8 N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a De no te s no v is ib le b an d b 8 (8 % ) o f t he 9 9 P. fa lc ip ar um d ilu tio n sa m pl es s et s w er e 20 0 an d 50 00 p ar as ite s/ µl a nd 2 (6 % ) o f t he 3 5 P. v iv ax d ilu tio n sa m pl e se ts w er e 20 0 an d 50 00 p ar as ite s/ µl c Ca lc ul at io ns in cl ud e in va lid te st s d Re su lts fo r p f- H RP 2 lin e/ pf -p LD H li ne , r es pe ct iv el y Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)78 Ta bl e A 4. 3: D is tr ib ut io n of P an /P v te st b an d in te ns it y (0 -4 ) sc or es f or P ha se 2 w ild t yp e P. v iv ax s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pe rc en ta ge d ist rib ut io n of p an o r Pv te st b an d in te ns ity e (n =1 40 ) Pe rc en ta ge d ist rib ut io n of p an o r Pv te st b an d in te ns ity e (n =7 0) 0a 1 2 3 4 0a 1 2 3 4 Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 10 0. 0 0. 0 0. 0 0. 0 0. 0 27 .1 40 .0 30 .0 2. 9 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 5. 7 32 .1 49 .3 12 .1 0. 7 0. 0 0. 0 0. 0 14 .3 85 .7 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 9. 3 49 .3 36 .4 5. 0 0. 0 0. 0 0. 0 0. 0 10 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 1. 4 6. 4 63 .6 23 .6 5. 0 0. 0 0. 0 0. 0 0. 0 10 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 0. 7 9. 3 60 .0 26 .4 3. 6 0. 0 0. 0 0. 0 2. 9 97 .1 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 65 .0 27 .9 7. 1 0. 0 0. 0 0. 0 1. 4 17 .1 28 .6 52 .9 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 18 .7 41 .7 33 .1 5. 8 0. 7 1. 4 0. 0 2. 9 10 .0 85 .7 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 18 .6 40 .7 39 .3 1. 4 0. 0 2. 9 0. 0 0. 0 14 .3 82 .9 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 62 .9 25 .7 10 .7 0. 7 0. 0 0. 0 1. 4 11 .4 35 .7 51 .4 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 11 .4 32 .9 43 .6 10 .7 1. 4 0. 0 0. 0 4. 3 5. 7 90 .0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 57 .1 36 .4 6. 4 0. 0 0. 0 4. 3 0. 0 31 .4 37 .1 27 .1 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 69 .3 19 .3 11 .4 0. 0 0. 0 11 .4 27 .1 51 .4 7. 1 2. 9 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 96 .4 3. 6 0. 0 0. 0 0. 0 2. 9 21 .4 61 .4 8. 6 5. 7 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 72 .9 25 .7 1. 4 0. 0 0. 0 1. 4 2. 9 55 .7 32 .9 7. 1 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 20 .0 27 .9 50 .0 2. 1 0. 0 2. 9 0. 0 5. 7 10 .0 81 .4 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 93 .6 6. 4 0. 0 0. 0 0. 0 1. 4 8. 6 58 .6 17 .1 14 .3 N an oS ig n M al ar ia P f/ Pv A g RM AD 10 Bi ol an d, L td 82 .9 15 .0 2. 1 0. 0 0. 0 0. 0 4. 3 47 .1 28 .6 20 .0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 7. 9 38 .6 44 .3 7. 9 1. 4 2. 9 0. 0 2. 9 8. 6 85 .7 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 5. 7 39 .3 48 .6 6. 4 0. 0 0. 0 0. 0 0. 0 27 .1 72 .9 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 7 1. 4 42 .1 34 .3 21 .4 1. 4 1. 4 0. 0 1. 4 95 .7 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 22 .9 28 .6 43 .6 1. 4 3. 6 0. 0 0. 0 4. 3 8. 6 87 .1 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 7 17 .1 50 .7 27 .9 3. 6 0. 0 0. 0 0. 0 2. 9 97 .1 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 7 17 .9 51 .4 25 .0 5. 0 0. 0 0. 0 0. 0 1. 4 98 .6 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 79 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pe rc en ta ge d ist rib ut io n of p an o r Pv te st b an d in te ns ity e (n =1 40 ) Pe rc en ta ge d ist rib ut io n of p an o r Pv te st b an d in te ns ity e (n =7 0) 0a 1 2 3 4 0a 1 2 3 4 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 95 .0 5. 0 0. 0 0. 0 0. 0 0. 0 15 .7 45 .7 32 .9 5. 7 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 96 .4 3. 6 0. 0 0. 0 0. 0 88 .6 10 .0 1. 4 0. 0 0. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 39 .3 27 .9 28 .6 4. 3 0. 0 0. 0 0. 0 1. 4 15 .7 82 .9 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 7 10 .7 48 .6 36 .4 3. 6 0. 0 0. 0 0. 0 7. 1 92 .9 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 16 .4 19 .3 52 .9 10 .7 0. 7 1. 4 0. 0 0. 0 5. 7 92 .9 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 10 0. 0 0. 0 0. 0 0. 0 0. 0 58 .6 34 .3 7. 1 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 0. 7 17 .9 56 .4 25 .0 0. 0 0. 0 0. 0 0. 0 2. 9 97 .1 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf c M AL -1 90 02 6 Co re D ia gn os tic s 95 .7 2. 1 0. 7 0. 0 1. 4 2. 9 20 .0 57 .1 20 .0 0. 0 Co re ™ M al ar ia P an /P v/ Pf d M AL -1 90 02 6 Co re D ia gn os tic s 75 .7 17 .1 6. 4 0. 7 0. 0 2. 9 2. 9 17 .1 40 .0 37 .1 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt ec M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 90 .7 8. 6 0. 0 0. 0 0. 7 4. 3 18 .6 55 .7 20 .0 1. 4 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt ed M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 68 .6 20 .7 10 .0 0. 7 0. 0 2. 9 5. 7 17 .1 35 .7 38 .6 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 5. 7 32 .9 51 .4 8. 6 1. 4 0. 0 0. 0 5. 7 11 .4 82 .9 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 24 .3 36 .4 35 .7 3. 6 0. 0 0. 0 0. 0 0. 0 14 .3 85 .7 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 18 .6 25 .7 47 .9 6. 4 1. 4 0. 0 0. 0 2. 9 0. 0 97 .1 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a De no te s no v is ib le b an d b 2 (6 % ) o f t he 3 5 P. v iv ax d ilu tio n sa m pl e se ts w er e 20 0 an d 50 00 p ar as ite s/ µl c Pa n te st li ne d P. vi va x te st li ne e Ca lc ul at io ns in cl ud e in va lid te st s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)80 Ta bl eA 4. 4: P an el d et ec tio n sc or e of P ha se 2 w ild t yp e P. f al ci pa ru m a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) by c on tin en t Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pa ne l d et ec tio n sc or ea b y co nt in en t of s am pl e or ig in Pa ne l d et ec tio n sc or ea b y co nt in en t of s am pl e or ig in Af ric a (n =6 2) As ia (n =2 0) So ut h Am er ic a (n =1 7) Af ric a (n =6 2) As ia (n =2 0) So ut h Am er ic a (n =1 7) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 91 .9 10 0. 0 94 .1 10 0. 0 10 0. 0 10 0. 0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 83 .9 90 .0 88 .2 98 .4 10 0. 0 10 0. 0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 77 .4 95 .0 94 .1 10 0. 0 10 0. 0 10 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 95 .2 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 83 .9 95 .0 88 .2 98 .4 10 0. 0 94 .1 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 79 .0 85 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 79 .0 10 0. 0 88 .2 10 0. 0 10 0. 0 10 0. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 61 .3 80 .0 76 .5 96 .8 10 0. 0 94 .1 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 61 .3 65 .0 52 .9 98 .4 10 0. 0 94 .1 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 83 .9 85 .0 94 .1 10 0. 0 10 0. 0 10 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 93 .6 10 0. 0 10 0. 0 98 .4 10 0. 0 10 0. 0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 85 .5 10 0. 0 94 .1 96 .8 10 0. 0 10 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 82 .3 90 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 77 .4 90 .0 82 .4 98 .4 10 0. 0 10 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )c 05 FK 90 St an da rd D ia gn os tic s In c. 85 .5 90 .0 94 .1 10 0. 0 10 0. 0 10 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 64 .5 85 .0 70 .6 10 0. 0 10 0. 0 94 .1 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 91 .9 10 0. 0 94 .1 98 .4 10 0. 0 10 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 80 .7 95 .0 82 .4 10 0. 0 10 0. 0 10 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 83 .9 10 0. 0 94 .1 10 0. 0 10 0. 0 10 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 82 .3 10 0. 0 88 .2 10 0. 0 10 0. 0 10 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 80 .7 95 .0 76 .5 10 0. 0 10 0. 0 10 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 69 .4 70 .0 70 .6 96 .8 10 0. 0 10 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 96 .8 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 82 .3 90 .0 88 .2 96 .8 10 0. 0 10 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 75 .8 85 .0 82 .4 98 .4 10 0. 0 10 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 72 .6 90 .0 70 .6 96 .8 10 0. 0 10 0. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 51 .6 65 .0 52 .9 96 .8 10 0. 0 94 .1 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 91 .9 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 3. 2 0. 0 0. 0 75 .8 75 .0 47 .1 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 83 .9 95 .0 64 .7 96 .8 10 0. 0 94 .1 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 72 .6 85 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 8. 1 5. 0 0. 0 90 .3 95 .0 82 .4 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 41 .9 40 .0 17 .7 93 .6 10 0. 0 94 .1 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 79 .0 90 .0 94 .1 10 0. 0 10 0. 0 10 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 50 .0 50 .0 52 .9 96 .8 10 0. 0 88 .2 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 91 .9 95 .0 76 .5 96 .8 10 0. 0 94 .1 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 91 .9 95 .0 94 .1 98 .4 10 0. 0 10 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 81 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r 20 0 pa ra sit es /µ l 20 00 b pa ra sit es /µ l Pa ne l d et ec tio n sc or ea b y co nt in en t of s am pl e or ig in Pa ne l d et ec tio n sc or ea b y co nt in en t of s am pl e or ig in Af ric a (n =6 2) As ia (n =2 0) So ut h Am er ic a (n =1 7) Af ric a (n =6 2) As ia (n =2 0) So ut h Am er ic a (n =1 7) SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 24 .2 5. 0 0. 0 95 .2 10 0. 0 82 .4 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 79 .0 95 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 87 .1 90 .0 82 .4 10 0. 0 10 0. 0 10 0. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 72 .6 90 .0 82 .4 98 .4 10 0. 0 10 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 90 .3 95 .0 10 0. 0 98 .4 95 .0 10 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 96 .8 10 0. 0 10 0. 0 10 0. 0 10 0. 0 10 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 74 .2 90 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 82 .3 90 .0 88 .2 10 0. 0 10 0. 0 10 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 90 .3 95 .0 10 0. 0 98 .4 10 0. 0 10 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 93 .6 95 .0 94 .1 98 .4 10 0. 0 10 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 83 .9 85 .0 70 .6 10 0. 0 10 0. 0 94 .1 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 22 .6 10 .0 0. 0 91 .9 95 .0 94 .1 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 24 .2 10 .0 0. 0 95 .2 90 .0 76 .5 Af ric a - U ni te d Re pu bl ic o f T an za ni a, C en tr al A fr ic an R ep ub lic , M ad ag as ca r, N ig er ia , K en ya , E th io pi a As ia - M ya nm ar , T he P hi lip pi ne s, Ca m bo di a So ut h Am er ic a - Pe ru , C ol om bi a Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a A sa m pl e is c on si de re d de te ct ed o nl y if al l R DT s fr om b ot h lo ts re ad b y th e fir st te ch ni ci an , a t m in im um s pe ci fie d re ad in g tim e, a re p os iti ve b 8 (8 % ) o f t he 9 9 P. fa lc ip ar um d ilu tio n sa m pl es s et s w er e 20 0 an d 50 00 p ar as ite s/ µl c PD S pr es en te d in th e ta bl e is b as ed o n a po si tiv e pf te st li ne (e ith er p f- H RP 2 or p f- pL DH ). P. fa lc ip ar um P DS b as ed o n in di vi du al te st li ne s w as : pf -p LD H ( 25 .8 , 5 , 0 % a t 2 00 p/ µl (A fr ic a/ As ia /S .A m er ic a) ; 9 6. 8, 9 5, 10 0% a t 2 00 0p /µ l ( Af ric a/ As ia /S . A m er ic a) a nd p f- H RP 2 (8 5. 5, 9 0, 94 .1 % a t 2 00 p/ µl (A fr ic a/ As ia /S .A m er ic a) ; 1 00 , 1 00 , 1 00 % a t 2 00 0p /µ l ( Af ric a/ As ia /S .A m er ic a) ) Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)82 Ta bl e A 4. 5: P . f al ci pa ru m t es t lin e fa ls e po si ti ve r at es f or P ha se 2 P . v iv ax s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. v iv ax s am pl es (n =3 5) 20 0 pa ra sit es /µ l 20 00 a pa ra sit es /µ l Fa ls e po si tiv e Pf in fe ct io nb ( % ) Fa ls e po si tiv e Pf in fe ct io nb ( % ) Lo t 1 (n =7 0) Lo t 2 (n =7 0) O ve ra ll (n =1 40 ) Lo t 1 (n =3 5) Lo t 2 (n =3 5) O ve ra ll (n =7 0) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 41 .4 38 .6 40 .0 37 .1 34 .3 35 .7 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 0. 0 0. 0 0. 0 2. 9 0. 0 1. 4 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 1. 5 (6 9) 5. 7 3. 6 (1 39 ) 0. 0 2. 9 1. 4 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 0. 0 0. 0 0. 0 2. 9 2. 9 2. 9 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 1. 4 0. 0 (6 9) 0. 7 (1 39 ) 0. 0 0. 0 0. 0 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 0. 0 1. 4 0. 7 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 0. 0 (6 8) 0. 0 0. 0 (1 38 ) 0. 0 (3 3) 2. 9 1. 5 (6 8) Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 2. 9 0. 0 1. 4 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 2. 9 1. 4 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )c 05 FK 90 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 2. 9 (6 9) 1. 4 (1 39 ) 2. 9 0. 0 1. 4 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 1. 4 0. 7 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 2. 9 1. 4 2. 1 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 5. 7 5. 7 5. 7 8. 6 2. 9 5. 7 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 (6 9) 1. 4 0. 7 (1 39 ) 0. 0 2. 9 1. 4 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 (3 4) 0. 0 0. 0 (6 9) IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 2. 9 4. 3 3. 6 5. 7 5. 7 5. 7 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 0. 0 0. 0 2. 9 0. 0 1. 4 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 2. 9 (6 8) 7. 1 5. 1 (1 38 ) 0. 0 0. 0 0. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 8. 6 22 .9 15 .7 8. 6 25 .7 17 .1 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 14 .3 1. 4 7. 9 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 (6 9) 0. 0 (1 39 ) 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 (6 8) 1. 5 (6 8) 0. 7 (1 36 ) 0. 0 (3 4) 0. 0 (3 4) 0. 0 (6 8) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 4. 3 1. 4 2. 9 0. 0 5. 7 2. 9 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 (6 9) 0. 0 0. 0 (1 39 ) 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 (6 8) 0. 0 (6 9) 0. 0 (1 37 ) 0. 0 (3 3) 0. 0 0. 0 (6 8) On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 31 .4 8. 8 (3 4) 20 .3 (6 9) Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 2. 9 1. 4 2. 1 5. 7 8. 6 7. 1 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 83 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. v iv ax s am pl es (n =3 5) 20 0 pa ra sit es /µ l 20 00 a pa ra sit es /µ l Fa ls e po si tiv e Pf in fe ct io nb ( % ) Fa ls e po si tiv e Pf in fe ct io nb ( % ) Lo t 1 (n =7 0) Lo t 2 (n =7 0) O ve ra ll (n =1 40 ) Lo t 1 (n =3 5) Lo t 2 (n =3 5) O ve ra ll (n =7 0) SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 2. 9 8. 6 5. 7 5. 7 2. 9 4. 3 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 1. 4 0. 7 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 0 1. 4 0. 7 0. 0 0. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 1. 4 1. 4 1. 4 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 (6 7) 0. 0 (1 37 ) 2. 9 0. 0 1. 4 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 (6 9) 0. 0 (1 39 ) 2. 9 (3 4) 2. 9 2. 9 (6 9) Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) N /A N /A N /A N /A N /A N /A di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s N /A N /A N /A N /A N /A N /A Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a 2 (6 % ) o f t he 3 5 P. v iv ax d ilu tio n sa m pl e se ts w er e 20 0 an d 50 00 p ar as ite s/ µl b Pf li ne p os iti ve in di ca te s a fa ls e po si tiv e P. fa lc ip ar um in fe ct io n c Bo th p f- H RP 2 an d pf -p LD H te st li ne s in di vi du al ly re tu rn ed 0 % fa ls e po si tiv e ra te s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)84 Ta bl e A 4. 6: P an ( or P v) t es t lin e fa ls e po si ti ve r at e fo r no n- Pf in fe ct io n on P ha se 2 P . f al ci pa ru m s am pl es a t lo w ( 20 0) a nd h ig h (2 00 0) p ar as it e de ns iti es ( pa ra si te s/ µl ) Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =9 9) 20 0 pa ra sit es /µ l 20 00 a pa ra sit es /µ l Fa lse p os iti ve n on -P f in fe ct io n (% ) Fa lse p os iti ve n on -P f in fe ct io n (% ) Lo t 1 (n =1 98 ) Lo t 2 (n =1 98 ) O ve ra ll (n =3 96 ) Lo t 1 (n =9 9) Lo t 2 (n =9 9) O ve ra ll (n =1 98 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 5 4. 0 2. 3 0. 0 0. 0 (9 8) 0. 0 (1 97 ) Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 2. 5 1. 3 0. 0 0. 0 6. 1 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 1. 0 2. 5 1. 8 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 5 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 (1 96 ) 0. 0 (3 94 ) 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 1. 0 0. 0 (1 96 ) 0. 5 (3 94 ) 0. 0 0. 0 (9 8) 0. 0 (1 97 ) IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 0. 5 3. 1 (1 97 ) 1. 8 (3 95 ) 0. 0 1. 0 0. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 2. 0 3. 5 2. 8 0. 0 1. 0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 (1 97 ) 0. 0 0. 0 (3 95 ) 0. 0 0. 0 8. 1 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 (1 97 ) 0. 0 (1 97 ) 0. 0 (3 94 ) 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 5 (1 97 ) 1. 5 (1 95 ) 1. 0 (3 92 ) 0. 0 (9 5) 0. 0 (9 8) 1. 0 (1 93 ) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 5 0. 5 0. 5 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 5. 2 (1 91 ) 11 .5 (1 92 ) 8. 4 (3 83 ) 0. 0 (9 5) 2. 0 (9 8) 0. 0 (1 93 ) On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 2. 5 1. 3 0. 0 0. 0 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 2. 0 1. 0 1. 5 1. 0 1. 0 0. 5 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 2. 0 (1 96 ) 1. 0 (3 94 ) 0. 0 1. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 1. 0 (1 96 ) 0. 5 (3 94 ) 0. 0 0. 0 0. 5 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 85 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r P. f al ci pa ru m s am pl es (n =9 9) 20 0 pa ra sit es /µ l 20 00 a pa ra sit es /µ l Fa lse p os iti ve n on -P f in fe ct io n (% ) Fa lse p os iti ve n on -P f in fe ct io n (% ) Lo t 1 (n =1 98 ) Lo t 2 (n =1 98 ) O ve ra ll (n =3 96 ) Lo t 1 (n =9 9) Lo t 2 (n =9 9) O ve ra ll (n =1 98 ) SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 1. 0 0. 5 0. 8 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 18 .3 (1 97 ) 13 .1 15 .7 (3 95 ) 16 .2 16 .2 8. 1 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 1. 0 0. 5 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 0 0. 5 0. 3 3. 0 2. 0 1. 5 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 5 0. 3 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 1. 5 9. 1 5. 3 12 .1 30 .3 6. 1 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 5 (1 95 ) 0. 0 (1 96 ) 0. 3 (3 91 ) 0. 0 (9 8) 0. 0 0. 0 (1 97 ) di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 (1 93 ) 0. 0 (1 96 ) 0. 0 (3 89 ) 0. 0 (9 7) 0. 0 0. 0 (1 96 ) Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) N /A N /A N /A N /A N /A N /A di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s N /A N /A N /A N /A N /A N /A Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a 8 (8 % ) o f t he 9 9 P. fa lc ip ar um d ilu tio n sa m pl es s et s w er e 20 0 an d 50 00 p ar as ite s/ µl Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)86 Ta bl e A 4. 7: P ha se 2 f al se p os iti ve r at e fo r P. f al ci pa ru m t es t lin e re su lt s on a ll m al ar ia -n eg at iv e sa m pl es Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on c le an a ne ga tiv e sa m pl es Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on s am pl es c on ta in in g no n- Pl as m od iu m s pp . i nf ec tio us a ge nt sb Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on s am pl es c on ta in in g im m un ol og ic al f ac to rs c Lo t 1 (n =1 00 ) Lo t 2 (n =1 00 ) O ve ra ll (n =2 00 ) Lo t 1 (n =4 2) Lo t 2 (n =4 2) O ve ra ll (n =8 4) Lo t 1 (n =5 8) Lo t 2 (n =5 8) O ve ra ll (n =1 16 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 38 .0 39 .0 38 .5 23 .8 28 .6 26 .2 50 .0 33 .3 (5 7) 41 .7 (1 15 ) BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 2. 0 2. 0 2. 0 0. 0 0. 0 0. 0 3. 5 3. 5 3. 5 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 2. 0 (9 9) 0. 0 (9 9) 1. 0 (1 98 ) 0. 0 0. 0 (4 1) 0. 0 (8 3) 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 3. 0 (9 9) 5. 0 4. 0 (1 99 ) 0. 0 0. 0 0. 0 6. 9 6. 9 6. 9 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 0. 0 0. 0 0. 0 2. 4 0. 0 1. 2 3. 5 3. 5 3. 5 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 1. 0 1. 0 1. 0 4. 8 4. 9 (4 1) 4. 8 (8 3) 12 .1 12 .1 12 .1 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 5. 2 5. 2 5. 2 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 3. 0 4. 0 3. 5 0. 0 0. 0 0. 0 6. 9 5. 2 6. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 1. 0 2. 0 1. 5 0. 0 0. 0 0. 0 0. 0 (5 7) 0. 0 0. 0 (1 15 ) Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 1. 0 0. 0 0. 5 2. 4 2. 4 2. 4 1. 7 0. 0 0. 9 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 10 .3 8. 6 9. 5 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 2. 0 3. 0 2. 5 2. 4 0. 0 1. 2 8. 6 10 .3 9. 5 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )d 05 FK 90 St an da rd D ia gn os tic s In c. 2/ 0 2/ 0 2/ 0 0/ 0 0/ 0 0/ 0 0/ 0 0/ 0 0/ 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 2. 0 4. 0 (9 9) 3. 0 (1 99 ) 0. 0 0. 0 0. 0 5. 2 6. 9 6. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H/ HR P2 /H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 7 0. 9 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 6. 9 5. 2 6. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 5. 0 0. 0 (9 9) 2. 5 (1 99 ) 2. 4 0. 0 1. 2 5. 2 8. 6 6. 9 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 1. 0 6. 0 3. 5 0. 0 0. 0 0. 0 1. 7 6. 9 4. 3 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 1. 0 0. 5 7. 1 9. 8 (4 1) 8. 4 (8 3) 1. 7 1. 7 1. 7 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 3. 0 2. 0 2. 5 7. 1 0. 0 3. 6 1. 7 0. 0 0. 9 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 2. 0 3. 0 2. 5 0. 0 0. 0 0. 0 3. 5 10 .3 6. 9 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 (9 9) 0. 0 0. 0 (1 99 ) 7. 1 9. 5 8. 3 0. 0 3. 5 1. 7 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 1. 0 1. 0 1. 0 0. 0 0. 0 0. 0 3. 5 5. 2 4. 3 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 19 .0 30 .0 24 .5 9. 5 4. 8 7. 1 6. 9 29 .3 18 .1 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 10 .0 1. 0 (9 9) 5. 5 (1 99 ) 0. 0 (4 1) 0. 0 0. 0 (8 3) 5. 2 3. 5 4. 3 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 (9 9) 0. 0 (9 9) 0. 0 (1 98 ) 0. 0 4. 8 2. 4 10 .3 8. 6 9. 5 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 1. 0 (9 8) 1. 0 (9 7) 1. 0 (1 95 ) 0. 0 0. 0 0. 0 1. 8 (5 7) 0. 0 (5 6) 0. 9 (1 13 ) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 1. 0 0. 5 2. 4 4. 8 3. 6 3. 5 6. 9 5. 2 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 (9 6) 0. 0 (9 9) 0. 0 (1 95 ) 0. 0 2. 4 1. 2 7. 0 (5 7) 6. 9 7. 0 (1 15 ) On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 2. 0 1. 0 0. 0 0. 0 0. 0 3. 5 3. 5 3. 5 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 2. 0 2. 0 (9 8) 2. 0 (1 98 ) 0. 0 0. 0 0. 0 13 .8 14 .6 (5 5) 14 .2 (1 13 ) Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 4. 0 (9 9) 3. 0 3. 5 (1 99 ) 2. 4 0. 0 (4 0) 1. 2 (8 2) 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 87 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on c le an a ne ga tiv e sa m pl es Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on s am pl es c on ta in in g no n- Pl as m od iu m s pp . i nf ec tio us a ge nt sb Pe rc en ta ge o f fa lse p os iti ve P f te st li ne s on s am pl es c on ta in in g im m un ol og ic al f ac to rs c Lo t 1 (n =1 00 ) Lo t 2 (n =1 00 ) O ve ra ll (n =2 00 ) Lo t 1 (n =4 2) Lo t 2 (n =4 2) O ve ra ll (n =8 4) Lo t 1 (n =5 8) Lo t 2 (n =5 8) O ve ra ll (n =1 16 ) SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 3. 0 4. 0 (9 9) 3. 5 (1 99 ) 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 1. 0 1. 0 1. 0 0. 0 0. 0 0. 0 6. 9 6. 9 6. 9 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne Te st IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 18 .0 9. 0 13 .5 7. 3 (4 1) 7. 1 7. 2 (8 3) 31 .0 19 .0 25 .0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 4. 0 4. 0 4. 0 0. 0 0. 0 0. 0 8. 6 6. 9 7. 8 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 4. 0 2. 0 3. 0 0. 0 0. 0 0. 0 0. 0 0. 0 (5 7) 0. 0 (1 15 ) M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st De vi ce M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 (9 9) 0. 0 (1 99 ) 0. 0 0. 0 0. 0 5. 2 3. 5 4. 3 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 0. 0 1. 0 0. 5 0. 0 0. 0 0. 0 3. 5 5. 2 4. 3 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 3. 0 4. 1 (9 8) 3. 5 (1 98 ) 0. 0 0. 0 0. 0 0. 0 1. 8 (5 7) 0. 9 (1 15 ) di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 3. 0 3. 0 (9 9) 3. 0 (1 99 ) 0. 0 (4 1) 0. 0 0. 0 (8 3) 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ica l I nn ov at io ns ) 4. 0 23 .0 13 .5 0. 0 (4 1) 2. 4 1. 2 (8 3) 1. 8 (5 7) 5. 2 3. 5 (1 15 ) di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 1. 0 0. 5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a bl oo d sa m pl es fr om h ea lth y vo lu nt ee rs w ith n o kn ow n cu rr en t i lln es s or b lo od a bn or m al ity b se e Ta bl e A4 .8 fo r d et ai ls c se e Ta bl e A4 .9 fo r d et ai ls d Re su lts fo r p f- H RP 2 lin e/ pf -p LD H li ne , r es pe ct iv el y Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)88 Ta bl e A 4. 8: P ha se 2 f al se p os iti ve r at e fo r P. f al ci pa ru m in s am pl es c on ta in in g sp ec ifi c no n- m al ar ia l i nf ec tio us p at ho ge ns Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve f or P la sm od iu m s pp . b y in fe ct io us p at ho ge n De ng ue Sc hi st os om ia sis Le ish m an ia sis Ch ag as Lo t 1 (n =8 ) Lo t 2 (n =8 ) Lo t 1 (n =2 0) Lo t 2 (n =2 0) Lo t 1 (n =1 0) Lo t 2 (n =1 0) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 0. 0 37 .5 25 .0 15 .0 30 .0 30 .0 50 .0 75 .0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 (1 9) 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 10 .0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 12 .5 25 .0 5. 0 0. 0 (1 9) 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 5. 0 0. 0 0. 0 25 .0 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 5. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )a 05 FK 90 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 0. 0 0. 0 5. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 10 .0 22 .2 (9 ) 50 .0 50 .0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 20 .0 0. 0 25 .0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 20 .0 75 .0 50 .0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 0. 0 0. 0 5. 0 10 .0 0. 0 0. 0 0. 0 0. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 50 .0 50 .0 10 .0 5. 0 10 .0 10 .0 50 .0 50 .0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 0. 0 (1 9) 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 25 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 12 .5 0. 0 0. 0 5. 0 0. 0 10 .0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 15 .0 10 .0 20 .0 0. 0 0. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 37 .5 10 0. 0 5. 0 70 .0 20 .0 50 .0 0. 0 25 .0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 (6 ) 5. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 89 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve f or P la sm od iu m s pp . b y in fe ct io us p at ho ge n De ng ue Sc hi st os om ia sis Le ish m an ia sis Ch ag as Lo t 1 (n =8 ) Lo t 2 (n =8 ) Lo t 1 (n =2 0) Lo t 2 (n =2 0) Lo t 1 (n =1 0) Lo t 2 (n =1 0) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 0. 0 (7 ) 0. 0 15 .0 0. 0 10 .0 30 .0 0. 0 25 .0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 50 .0 50 .0 30 .0 60 .0 20 .0 20 .0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 (1 9) 0. 0 0. 0 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 0. 0 (7 ) 12 .5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)90 Ta bl e A 4. 9: P ha se 2 f al se p os iti ve r at e fo r P. f al ci pa ru m in s am pl es c on ta in in g po te nt ia lly c ro ss -r ea ct in g bl oo d im m un ol og ic al f ac to rs Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve f or P la sm od iu m s pp . b y bl oo d im m un ol og ic al f ac to r Rh eu m at oi d fa ct or An ti- nu cl ea r an tib od ie s An ti- m ou se a nt ib od ie s Ra pi d pl as m a re ag in (R PR ) po sit iv e Lo t 1 (n =8 ) Lo t 2 (n =8 ) Lo t 1 (n =2 6) Lo t 2 (n =2 6) Lo t 1 (n =6 ) Lo t 2 (n =6 ) Lo t 1 (n =1 8) Lo t 2 (n =1 8) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 62 .5 50 .0 57 .7 15 .4 50 .0 66 .7 33 .3 41 .2 (1 7) BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 25 .0 25 .0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 66 .7 50 .0 0. 0 5. 6 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 33 .3 33 .3 0. 0 0. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 62 .5 37 .5 0. 0 0. 0 16 .7 33 .3 5. 6 11 .1 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 0. 0 33 .3 33 .3 5. 6 5. 6 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 25 .0 12 .5 0. 0 0. 0 33 .3 33 .3 0. 0 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 (2 5) 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 12 .5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 25 .0 25 .0 0. 0 0. 0 66 .7 50 .0 0. 0 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 25 .0 25 .0 0. 0 3. 9 50 .0 50 .0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )a 05 FK 90 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 25 .0 25 .0 0. 0 0. 0 16 .7 33 .3 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 33 .3 0. 0 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 25 .0 25 .0 0. 0 0. 0 33 .3 16 .7 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 25 .0 25 .0 0. 0 3. 9 16 .7 33 .3 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 25 .0 25 .0 3. 9 7. 7 33 .3 33 .3 5. 6 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 25 .0 25 .0 0. 0 0. 0 16 .7 33 .3 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 12 .5 0. 0 3. 9 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 25 .0 25 .0 3. 9 19 .2 33 .3 33 .3 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 25 .0 37 .5 0. 0 0. 0 0. 0 66 .7 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 50 .0 50 .0 0. 0 7. 7 66 .7 66 .7 0. 0 0. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 25 .0 50 .0 11 .5 50 .0 66 .7 83 .3 5. 6 16 .7 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 25 .0 25 .0 0. 0 0. 0 50 .0 33 .3 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 25 .0 25 .0 0. 0 3. 9 66 .7 33 .3 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 25 .0 28 .6 (7 ) 0. 0 (2 5) 0. 0 (2 5) 0. 0 0. 0 5. 6 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 7. 7 16 .7 16 .7 5. 6 5. 6 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 25 .0 50 .0 0. 0 7. 7 50 .0 50 .0 11 .8 (1 7) 11 .1 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 62 .5 10 0. 0 19 .2 73 .1 10 0. 0 10 0. 0 0. 0 38 .9 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 25 .0 25 .0 0. 0 0. 0 (2 5) 10 0. 0 10 0. 0 0. 0 0. 0 (1 6) Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 12 .5 0. 0 0. 0 0. 0 16 .7 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 91 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve f or P la sm od iu m s pp . b y bl oo d im m un ol og ic al f ac to r Rh eu m at oi d fa ct or An ti- nu cl ea r an tib od ie s An ti- m ou se a nt ib od ie s Ra pi d pl as m a re ag in (R PR ) po sit iv e Lo t 1 (n =8 ) Lo t 2 (n =8 ) Lo t 1 (n =2 6) Lo t 2 (n =2 6) Lo t 1 (n =6 ) Lo t 2 (n =6 ) Lo t 1 (n =1 8) Lo t 2 (n =1 8) Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 25 .0 25 .0 0. 0 0. 0 50 .0 50 .0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 50 .0 25 .0 26 .9 15 .4 50 .0 50 .0 50 .0 44 .4 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 37 .5 25 .0 0. 0 0. 0 33 .3 33 .3 0. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 (2 5) 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 50 .0 33 .3 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 87 .5 87 .5 53 .9 76 .9 66 .7 66 .7 5. 6 11 .1 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 25 .0 12 .5 0. 0 0. 0 (2 5) 0. 0 16 .7 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 12 .5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ic al In no va tio ns ) 12 .5 0. 0 0. 0 0. 0 0. 0 (5 ) 50 .0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Bo th p f- H RP 2 an d pf -p LD H te st li ne s in di vi du al ly re tu rn ed 0 % fa ls e po si tiv e ra te s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)92 Ta bl e A 4. 10 : P ha se 2 f al se p os iti ve r at e of p an t es t lin e re su lt s on a ll m al ar ia -n eg at iv e sa m pl es Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on c le an a ne ga tiv e sa m pl es Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on s am pl es c on ta in in g no n- Pl as m od iu m s pp . i nf ec tio us a ge nt sb Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on s am pl es c on ta in in g im m un ol og ic al f ac to rs c Lo t 1 (n =1 00 ) Lo t 2 (n =1 00 ) O ve ra ll (n =2 00 ) Lo t 1 (n =4 2) Lo t 2 (n =4 2) O ve ra ll (n =8 4) Lo t 1 (n =5 8) Lo t 2 (n =5 8) O ve ra ll (n =1 16 ) Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P . f al cip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 2. 0 1. 0 (9 9) 1. 5 (1 99 ) 0. 0 0. 0 0. 0 5. 2 6. 9 6. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3. 5 1. 7 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 1. 0 0. 5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 0. 0 0. 0 (9 9) 0. 0 (1 99 ) 0. 0 0. 0 0. 0 0. 0 1. 7 0. 9 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 8. 6 6. 9 7. 8 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 1. 0 0. 5 0. 0 0. 0 (4 1) 0. 0 (8 3) 3. 5 5. 2 4. 3 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 7 0. 0 0. 9 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 6. 9 8. 6 7. 8 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 1. 0 (9 9) 0. 0 0. 5 (1 99 ) 0. 0 0. 0 0. 0 3. 5 8. 6 6. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 1. 0 3. 0 2. 0 2. 4 4. 8 3. 6 13 .8 17 .2 15 .5 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • G es el ls ch af t f ür D ia gn os tik a m bH 39 .0 47 .0 43 .0 21 .4 19 .1 20 .2 17 .2 43 .1 30 .2 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 (9 9) 0. 0 (1 99 ) 0. 0 (4 1) 0. 0 0. 0 (8 3) 6. 9 6. 9 6. 9 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 (9 9) 0. 0 (9 9) 0. 0 (1 98 ) 0. 0 0. 0 0. 0 6. 9 6. 9 6. 9 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 (9 8) 0. 0 (9 7) 0. 0 (1 95 ) 0. 0 0. 0 0. 0 3. 5 (5 7) 3. 6 (5 6) 3. 5 (1 13 ) N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 3. 1 (9 6) 5. 1 (9 9) 4. 1 (1 95 ) 2. 4 11 .9 7. 1 10 .5 (5 7) 19 .0 14 .8 (1 15 ) On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 13 .0 42 .0 27 .5 14 .3 66 .7 40 .5 27 .6 69 .0 48 .3 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 2. 0 2. 0 (9 8) 2. 0 (1 98 ) 0. 0 0. 0 0. 0 8. 6 7. 3 (5 5) 8. 0 (1 13 ) Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 (9 9) 0. 0 0. 0 (1 99 ) 0. 0 0. 0 (4 0) 0. 0 (8 2) 3. 5 0. 0 1. 7 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 2. 0 2. 0 (9 9) 2. 0 (1 99 ) 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 93 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on c le an a ne ga tiv e sa m pl es Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on s am pl es c on ta in in g no n- Pl as m od iu m s pp . i nf ec tio us a ge nt sb Pe rc en ta ge o f fa lse p os iti ve p an te st li ne s on s am pl es c on ta in in g im m un ol og ic al f ac to rs c Lo t 1 (n =1 00 ) Lo t 2 (n =1 00 ) O ve ra ll (n =2 00 ) Lo t 1 (n =4 2) Lo t 2 (n =4 2) O ve ra ll (n =8 4) Lo t 1 (n =5 8) Lo t 2 (n =5 8) O ve ra ll (n =1 16 ) Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 5. 2 5. 2 5. 2 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 13 .0 6. 0 9. 5 7. 3 (4 1) 4. 8 6. 0 (8 3) 27 .6 22 .4 25 .0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 2. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 (5 7) 0. 0 (1 15 ) M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 (9 9) 0. 0 (1 99 ) 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 26 .0 30 .0 28 .0 28 .6 42 .9 35 .7 43 .1 56 .9 50 .0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf d M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 (9 8) 0. 0 (1 98 ) 0. 0 0. 0 0. 0 3. 5 1. 8 (5 7) 2. 6 (1 15 ) Co re ™ M al ar ia P an /P v/ Pf e M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 (9 8) 0. 0 (1 98 ) 0. 0 0. 0 0. 0 0. 0 0. 0 (5 7) 0. 0 (1 15 ) di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt ed M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 1. 0 1. 0 (9 9) 1. 0 (1 99 ) 0. 0 (4 1) 0. 0 0. 0 (8 3) 1. 7 0. 0 0. 9 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt ee M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 (9 9) 0. 0 (1 99 ) 0. 0 (4 1) 0. 0 0. 0 (8 3) 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (I nv er ne ss M ed ica l I nn ov at io ns ) 4. 0 23 .0 13 .5 0. 0 (4 1) 2. 4 1. 2 (8 3) 1. 8 (5 7) 5. 2 3. 5 (1 15 ) di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 1. 0 0. 5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Bl oo d sa m pl es fr om h ea lth y vo lu nt ee rs w ith n o kn ow n cu rr en t i lln es s or b lo od a bn or m al ity b Se e Ta bl e A4 .8 fo r d et ai ls c Se e Ta bl e A4 .9 fo r d et ai ls d Pa n te st li ne e P. v iv ax te st li ne Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)94 Ta bl e A 4. 11 : H ea t st ab ili ty t es tin g re su lt s fo r P. f al ci pa ru m ( or p an a ) t es t lin e on a P . f al ci pa ru m s am pl es a t lo w p ar as it e de ns it y (2 00 p ar as it es /µ l) . Po si ti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 2 15 .0 0. 0 2. 0 13 .0 2. 0 2. 0 13 .0 0. 0 1. 9 15 .0 0. 0 2. 7 15 .0 0. 0 2. 2 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 15 .0 0. 0 2. 9 15 .0 0. 0 2. 8 15 .0 0. 0 2. 0 15 .0 0. 0 2. 5 15 .0 0. 0 1. 9 15 .0 0. 0 2. 3 15 .0 0. 0 2. 7 15 .0 0. 0 2. 5 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 15 .0 0. 0 3. 2 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 14 .0 1. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 3. 6 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 15 .0 0. 0 3. 1 15 .0 0. 0 2. 9 15 .0 0. 0 2. 1 15 .0 0. 0 2. 5 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 9 15 .0 0. 0 2. 5 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 1. 9 15 .0 0. 0 1. 9 15 .0 0. 0 1. 0 15 .0 0. 0 1. 3 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 15 .0 0. 0 2. 2 14 .0 0. 0 2. 0 15 .0 0. 0 2. 4 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ica l ( Be ijin g) C o. , L td . 13 .0 0. 0 1. 0 6. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 5. 0 0. 0 1. 0 1. 0 0. 0 1. 0 On e St ep M al ar ia P .f Te st W 37 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 15 .0 0. 0 2. 0 15 .0 0. 0 1. 7 15 .0 0. 0 1. 4 13 .0 0. 0 1. 2 12 .0 0. 0 1. 6 15 .0 0. 0 1. 5 14 .0 0. 0 1. 4 13 .0 0. 0 1. 5 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 15 .0 0. 0 2. 1 14 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 15 .0 0. 0 3. 3 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 3. 7 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 15 .0 0. 0 2. 3 15 .0 0. 0 3. 0 15 .0 0. 0 2. 7 15 .0 0. 0 2. 8 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 3. 0 14 .0 0. 0 2. 5 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 15 .0 0. 0 2. 8 15 .0 0. 0 2. 2 14 .0 0. 0 2. 0 15 .0 0. 0 2. 9 15 .0 0. 0 2. 1 15 .0 0. 0 2. 1 15 .0 0. 0 2. 0 15 .0 0. 0 2. 7 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 10 .0 0. 0 1. 7 7. 0 1. 0 1. 4 15 .0 0. 0 1. 9 15 .0 0. 0 1. 9 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )b 05 FK 90 St an da rd D ia gn os tic s In c. 15 .0 0. 0 2. 4/ 0. 0 15 .0 0. 0 2. 0/ 0. 0 15 .0 0. 0 2. 0/ 0. 0 15 .0 0. 0 2. 0/ 0. 0 15 .0 0. 0 1. 9/ 0. 0 15 .0 0. 0 3. 0/ 0. 0 15 .0 0. 0 2. 0/ 0. 0 15 .0 0. 0 3. 0/ 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) Co . L td . 15 .0 0. 0 1. 7 15 .0 0. 0 1. 0 9. 0 0. 0 1. 0 15 .0 0. 0 1. 0 14 .0 0. 0 1. 1 13 .0 0. 0 1. 1 15 .0 0. 0 1. 0 15 .0 0. 0 1. 5 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 15 .0 0. 0 2. 1 15 .0 0. 0 3. 0 15 .0 0. 0 3. 4 15 .0 0. 0 2. 9 15 .0 0. 0 2. 6 14 .0 0. 0 2. 1 15 .0 0. 0 3. 0 14 .0 1. 0 3. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 15 .0 0. 0 3. 0 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 2. 3 15 .0 0. 0 2. 0 15 .0 0. 0 2. 9 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 15 .0 0. 0 2. 9 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 15 .0 0. 0 1. 8 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 9 15 .0 0. 0 3. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 15 .0 0. 0 3. 0 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 15 .0 0. 0 1. 9 13 .0 0. 0 2. 0 15 .0 0. 0 2. 7 14 .0 0. 0 2. 9 15 .0 0. 0 2. 9 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 15 .0 0. 0 2. 9 15 .0 0. 0 2. 5 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 2. 5 15 .0 0. 0 2. 3 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 15 .0 0. 0 2. 1 15 .0 0. 0 2. 6 15 .0 0. 0 2. 7 15 .0 0. 0 2. 0 14 .0 0. 0 1. 9 15 .0 0. 0 1. 9 15 .0 0. 0 1. 7 15 .0 0. 0 2. 9 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 15 .0 0. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 3. 9 15 .0 0. 0 4. 0 14 .0 1. 0 3. 9 15 .0 0. 0 3. 3 15 .0 0. 0 4. 0 15 .0 0. 0 3. 3 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 15 .0 0. 0 2. 9 15 .0 0. 0 2. 4 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 14 .0 1. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 2. 2 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 15 .0 0. 0 2. 2 15 .0 0. 0 2. 8 15 .0 0. 0 2. 9 15 .0 0. 0 1. 9 14 .0 0. 0 1. 9 14 .0 0. 0 2. 0 15 .0 0. 0 1. 8 15 .0 0. 0 2. 8 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 1. 7 15 .0 0. 0 1. 8 15 .0 0. 0 1. 0 15 .0 0. 0 1. 0 14 .0 0. 0 1. 8 15 .0 0. 0 1. 9 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 15 .0 0. 0 1. 0 3. 0 0. 0 1. 0 5. 0 0. 0 1. 4 5. 0 0. 0 1. 2 3. 0 0. 0 1. 3 4. 0 0. 0 1. 3 11 .0 0. 0 1. 3 1. 0 0. 0 1. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 15 .0 0. 0 3. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 1. 9 15 .0 0. 0 2. 2 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia Pf /P an 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 15 .0 0. 0 2. 3 14 .0 1. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 3. 0 14 .0 1. 0 3. 0 15 .0 0. 0 3. 0 15 .0 0. 0 3. 7 15 .0 0. 0 3. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 95 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 8. 0 0. 0 1. 0 6. 0 0. 0 1. 8 0. 0 0. 0 0. 0 4. 0 0. 0 1. 0 0. 0 0. 0 0. 0 8. 0 0. 0 1. 0 0. 0 0. 0 0. 0 6. 0 0. 0 1. 3 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 9. 0 0. 0 1. 0 0. 0 0. 0 0. 0 Pa ra sc re en ™ De vi ce - Ra pi d te st fo r M al ar ia Pa n/ Pf 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 15 .0 0. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 15 .0 0. 0 2. 4 15 .0 0. 0 2. 1 14 .0 1. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 9 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/P an R ap id Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 15 .0 0. 0 2. 0 14 .0 0. 0 1. 7 15 .0 0. 0 1. 0 15 .0 0. 0 1. 7 15 .0 0. 0 1. 3 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 1. 8 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 14 .0 0. 0 2. 0 15 .0 0. 0 2. 5 14 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 15 .0 0. 0 2. 1 15 .0 0. 0 3. 0 14 .0 1. 0 2. 9 15 .0 0. 0 2. 8 15 .0 0. 0 2. 5 15 .0 0. 0 2. 0 15 .0 0. 0 3. 0 15 .0 0. 0 3. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 15 .0 0. 0 3. 2 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 14 .0 1. 0 4. 0 15 .0 0. 0 3. 9 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 15 .0 0. 0 1. 6 15 .0 0. 0 1. 6 15 .0 0. 0 1. 9 15 .0 0. 0 1. 5 15 .0 0. 0 1. 7 14 .0 0. 0 1. 3 15 .0 0. 0 2. 0 12 .0 0. 0 1. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 1 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 15 .0 0. 0 2. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 15 .0 0. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 14 .0 1. 0 3. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 15 .0 0. 0 4. 0 13 .0 2. 0 3. 9 15 .0 0. 0 3. 8 15 .0 0. 0 3. 8 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) 14 .0 1. 0 1. 0 15 .0 0. 0 1. 0 14 .0 0. 0 1. 1 14 .0 0. 0 1. 1 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 5 03 01 02 5 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Fo r p an -o nl y te st s b Re su lts fo r p f- H RP 2 lin e/ pf -p LD H li ne , r es pe ct iv el y Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)96 Ta bl e A 4. 11 a: H ea t st ab ili ty t es tin g re su lt s fo r pa n te st li ne o f co m bi na tio n RD Ts o n a P. f al ci pa ru m s am pl e at lo w p ar as it e de ns it y (2 00 p ar as it es /µ l) . Po si ti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity Pf a nd P an Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ica l ( Be ijin g) C o. , L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On e St ep M al ar ia P .f Te st W 37 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH ) 05 FK 90 St an da rd D ia gn os tic s In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 15 .0 0. 0 1. 3 15 .0 0. 0 1. 0 15 .0 0. 0 1. 8 15 .0 0. 0 1. 0 15 .0 0. 0 1. 1 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 1. 9 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 15 .0 0. 0 1. 3 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 1. 8 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 15 .0 0. 0 1. 4 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 15 .0 0. 0 1. 1 13 .0 0. 0 1. 1 15 .0 0. 0 2. 0 14 .0 0. 0 1. 9 15 .0 0. 0 1. 9 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 0. 0 0. 0 0. 0 4. 0 0. 0 1. 0 9. 0 0. 0 1. 6 7. 0 0. 0 1. 4 7. 0 0. 0 1. 4 5. 0 0. 0 1. 4 6. 0 0. 0 1. 3 2. 0 0. 0 1. 5 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - R ap id te st fo r M al ar ia P f/P an 5 04 02 02 5 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 2. 0 0. 0 1. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 97 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) Lo t 1 (n =1 5) Lo t 2 (n =1 5) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity On e St ep M al ar ia P .f/ Pa n Te st W 56 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 10 .0 0. 0 1. 0 10 .0 0. 0 1. 4 12 .0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 13 .0 0. 0 1. 7 7. 0 0. 0 1. 1 11 .0 0. 0 1. 4 14 .0 0. 0 1. 9 3. 0 0. 0 1. 0 3. 0 0. 0 1. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 9. 0 0. 0 1. 0 0. 0 0. 0 0. 0 Pa ra sc re en ™ De vi ce - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/P an R ap id Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V AZ OG , I nc . N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A N /A Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) 14 .0 1. 0 1. 0 15 .0 0. 0 1. 0 14 .0 0. 0 1. 1 14 .0 0. 0 1. 1 15 .0 0. 0 1. 9 15 .0 0. 0 2. 0 15 .0 0. 0 1. 0 15 .0 0. 0 2. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 5 03 01 02 5 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)98 Ta bl e A 4. 12 : H ea t st ab ili ty t es tin g re su lt s fo r P. f al ci pa ru m ( or p an a ) t es t lin e on a P . f al ci pa ru m s am pl es a t hi gh p ar as it e de ns it y (2 ,0 00 p ar as it es /µ l) . Po si ti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 4. 0 1. 0 4. 0 3. 0 2. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 5. 0 0. 0 4. 0 5. 0 0. 0 3. 6 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ica l (B eij in g) C o., Lt d. 5. 0 0. 0 3. 8 5. 0 0. 0 2. 6 5. 0 0. 0 2. 2 5. 0 0. 0 2. 2 5. 0 0. 0 1. 8 5. 0 0. 0 1. 8 5. 0 0. 0 3. 0 5. 0 0. 0 2. 4 On e St ep M al ar ia P .f Te st W 37 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 5. 0 0. 0 3. 4 5. 0 0. 0 4. 0 5. 0 0. 0 2. 8 5. 0 0. 0 3. 6 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 3. 4 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 4. 0 1. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 2. 8 5. 0 0. 0 3. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )b 05 FK 90 St an da rd D ia gn os tic s In c. 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 0 5. 0 0. 0 4. 0/ 1. 3 5. 0 0. 0 4. 0/ 1. 4 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. Lt d. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 0 5. 0 0. 0 4. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 5. 0 0. 0 2. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 4. 0 1. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 5. 0 0. 0 2. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 6 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 5. 0 0. 0 3. 8 5. 0 0. 0 2. 6 5. 0 0. 0 3. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 6 4. 0 0. 0 2. 0 5. 0 0. 0 2. 4 5. 0 0. 0 2. 8 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 2. 0 0. 0 1. 0 2. 0 0. 0 1. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 1. 0 0. 0 1. 0 M al as ca n™ D ev ic e - R ap id te st fo r M al ar ia P f/P an 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 4. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2. 0 0. 0 1. 0 an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 99 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity On e St ep M al ar ia P .f/ Pa n Te st W 56 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 5. 0 0. 0 3. 0 5. 0 0. 0 3. 8 5. 0 0. 0 3. 8 5. 0 0. 0 3. 6 5. 0 0. 0 3. 6 5. 0 0. 0 3. 4 5. 0 0. 0 3. 4 5. 0 0. 0 3. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 4. 0 0. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 Pa ra sc re en ™ De vi ce - Ra pi d te st fo r M al ar ia Pa n/ Pf 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 3. 0 0. 0 1. 0 5. 0 0. 0 1. 0 4. 0 0. 0 1. 0 5. 0 0. 0 1. 2 5. 0 0. 0 1. 8 Su re st ep ™ E as y M al ar ia P f/P an R ap id Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 TC 40 In Te c Pr od uc ts , I nc . 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 3. 6 5. 0 0. 0 3. 8 5. 0 0. 0 3. 8 5. 0 0. 0 3. 0 5. 0 0. 0 3. 6 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 5. 0 0. 0 2. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 4. 0 1. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs L td . ( In ve rn es s M ed ic al In no va tio ns ) 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 3. 2 5. 0 0. 0 3. 0 5. 0 0. 0 3. 0 5. 0 0. 0 2. 2 5. 0 0. 0 3. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 0. 0 2. 0 3. 0 0. 0 1. 3 5. 0 0. 0 1. 8 5. 0 0. 0 1. 8 3. 0 0. 0 2. 0 5. 0 0. 0 1. 6 5. 0 0. 0 1. 6 5. 0 0. 0 1. 6 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 4. 0 0. 0 2. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 5. 0 0. 0 1. 6 5. 0 0. 0 1. 6 5. 0 0. 0 1. 6 5. 0 0. 0 1. 8 5. 0 0. 0 1. 6 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Fo r p an -o nl y te st s b Re su lts fo r p f- H RP 2 lin e/ pf -p LD H li ne , r es pe ct iv el y Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)100 Ta bl e A 4. 12 a: H ea t st ab ili ty t es tin g re su lt s fo r pa n te st li ne o f co m bi na tio n RD Ts o n a P. f al ci pa ru m s am pl e at h ig h pa ra si te d en si ty ( 20 00 p ar as it es /µ l) . Po si ti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) Lo t 1 (n =5 ) Lo t 2 (n =5 ) No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity No. positive No. invalid Mean band intensity Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 5. 0 0. 0 1. 6 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 4. 0 0. 0 1. 3 2. 0 0. 0 1. 0 5. 0 0. 0 1. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 5. 0 0. 0 3. 6 5. 0 0. 0 3. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 6 5. 0 0. 0 4. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 3. 6 5. 0 0. 0 4. 0 5. 0 0. 0 3. 8 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 5. 0 0. 0 4. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 4. 0 0. 0 1. 0 5. 0 0. 0 1. 0 0. 0 0. 0 0. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 4. 0 0. 0 1. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 5. 0 0. 0 1. 6 0. 0 0. 0 0. 0 5. 0 0. 0 1. 0 4. 0 0. 0 1. 0 0. 0 0. 0 0. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 3. 0 0. 0 1. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 0. 0 2. 0 5. 0 0. 0 1. 4 4. 0 0. 0 1. 8 5. 0 0. 0 1. 2 4. 0 0. 0 1. 3 5. 0 0. 0 1. 0 5. 0 0. 0 1. 2 3. 0 0. 0 1. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 5. 0 0. 0 1. 0 4. 0 0. 0 1. 0 2. 0 0. 0 1. 0 1. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 3. 0 0. 0 1. 0 3. 0 0. 0 1. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 5. 0 0. 0 1. 2 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 3. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3. 0 0. 0 1. 0 5. 0 0. 0 1. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 5. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 4. 0 0. 0 1. 0 5. 0 0. 0 1. 0 M al ar ia P an T es t M AL - W 23 N -0 01 Di m a • G es el ls ch af t f ür Di ag no st ik a m bH 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 4. 0 0. 0 1. 5 2. 0 0. 0 2. 0 2. 0 0. 0 2. 0 2. 0 0. 0 1. 5 4. 0 0. 0 1. 5 2. 0 0. 0 1. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - R ap id te st fo r M al ar ia P f/P an 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 5. 0 0. 0 1. 4 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 5. 0 0. 0 1. 4 5. 0 0. 0 1. 4 5. 0 0. 0 1. 6 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C Gu an gz ho u W on df o Bi ot ec h Co . L td . 4. 0 0. 0 1. 0 3. 0 0. 0 1. 0 3. 0 0. 0 1. 3 5. 0 0. 0 1. 4 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 1. 0 0. 0 1. 0 4. 0 0. 0 1. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 5. 0 0. 0 1. 6 5. 0 0. 0 1. 0 5. 0 0. 0 2. 0 5. 0 0. 0 1. 8 5. 0 0. 0 2. 0 3. 0 0. 0 1. 7 5. 0 0. 0 1. 0 4. 0 0. 0 1. 3 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 4. 0 0. 0 2. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 Pa ra sc re en ™ De vi ce - Ra pi d te st fo r M al ar ia Pa n/ Pf 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 4. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 2. 0 5. 0 0. 0 1. 4 5. 0 0. 0 1. 6 5. 0 0. 0 1. 2 5. 0 0. 0 2. 0 5. 0 0. 0 2. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 5. 0 0. 0 2. 0 5. 0 0. 0 1. 4 5. 0 0. 0 1. 0 2. 0 0. 0 1. 0 4. 0 0. 0 1. 0 5. 0 0. 0 1. 4 5. 0 0. 0 1. 2 5. 0 0. 0 1. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 5. 0 0. 0 1. 0 3. 0 0. 0 1. 0 0. 0 0. 0 0. 0 2. 0 0. 0 1. 0 5. 0 0. 0 1. 0 4. 0 0. 0 1. 0 5. 0 0. 0 1. 2 5. 0 0. 0 1. 4 Su re st ep ™ E as y M al ar ia P f/P an R ap id Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 3. 0 0. 0 1. 0 5. 0 0. 0 1. 0 5. 0 0. 0 1. 0 0. 0 1. 0 0. 0 3. 0 0. 0 1. 0 4. 0 0. 0 1. 3 4. 0 0. 0 1. 0 3. 0 0. 0 1. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 5. 0 0. 0 1. 0 2. 0 0. 0 1. 5 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 4. 0 0. 0 1. 0 3. 0 0. 0 1. 3 3. 0 0. 0 1. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 101 Ta bl e A 4. 13 : H ea t st ab ili ty t es tin g re su lt s fo r P. f al ci pa ru m ( or p an ) te st li ne o n pa ra si te n eg at iv e sa m pl es . P os iti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid Pf o nl y Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f Te st IT P1 10 02 TC 40 In Te c Pr od uc ts , I nc . 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 2. 0 0. 0 4. 0 0. 0 0. 0 0. 0 1. 0 0. 0 BI ON OT E M AL AR IA P .f. A g Ra pi d Te st K it RG 19 -1 1 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia P .f. VB 01 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P f M AL -1 90 02 0 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia P .f. M L0 1 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT fa lc ip ar um 05 19 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f A g RM AF 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .F T es t ( ca ss et te ) 52 23 52 Bl ue C ro ss B io -M ed ic al (B ei jin g) C o. , L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f Te st W 37 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te P f A g Ra pi d Te st R0 11 4C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ev ic e- R ap id te st fo r P . f al ci pa ru m M al ar ia V er . 3 30 30 10 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ch ec k® P f D ip st ic k- R ap id te st fo r P. fa lc ip ar um M al ar ia V er . 3 30 30 20 25 Or ch id B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra H IT ® - f ( De vi ce ) 55 IC 10 2- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra H IT ® -f (D ip st ic k) 55 IC 10 1- 50 Sp an D ia gn os tic s Lt d. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f. (H RP 2/ pL DH )a 05 FK 90 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • Ge se lls ch af t f ür D ia gn os tik a m bH 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 1. 0 0. 0 0. 0 0. 0 1. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)102 Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf a nd P v Ad va nc ed Q ua lit y™ O ne S te p M al ar ia P .f/ P. v Tr i- Li ne T es t IT P1 10 03 T C4 0 In Te c Pr od uc ts , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ad va nt ag e M al ar ia C ar d IR 21 10 25 J. M itr a & C o. P vt . L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P .v. A g Ra pi d Te st K it RG 19 -1 2 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Co re ™ M al ar ia P v/ Pf M AL -1 90 02 2 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( H RP II ) / p v (p LD H ) A nt ig en D et ec tio n Te st D ev ic e M FV -1 24 V AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te M al ar ia P f/ Pv A g Ra pi d Te st R0 11 2C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 1. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa n on ly Cl ea rv ie w ® M al ar ia p LD H 70 88 40 25 Or ge ni cs Lt d. (In ve rn es s M ed ica l In no va tio ns ) 1. 0 0. 0 2. 0 0. 0 0. 0 0. 0 2. 0 0. 0 4. 0 0. 0 4. 0 0. 0 0. 0 0. 0 4. 0 0. 0 di ag no st ic ks M AL AR IA (P an ) C as se tt e M PN W BC 10 07 .3 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra ba nk ™ D ev ic e - Ra pi d te st fo r M al ar ia P an 50 30 10 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s a Bo th p f- H RP 2 an d pf -p LD H te st li ne s in di vi du al ly re tu rn ed 0 % p os iti vi ty ra te s Ta bl e A 4. 13 ( co nt in ue d) an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 103 Ta bl e A 4. 13 a: H ea t st ab ili ty t es tin g re su lt s fo r pa n te st li ne o f co m bi na tio n RD Ts o n pa ra si te n eg at iv e sa m pl es . P os iti vi ty r at e at b as el in e, a nd a ft er 6 0 da ys in cu ba tio n at 4 °C , 3 5° C an d 45 °C Pr od uc t Ca ta lo gu e nu m be r M an uf ac tu re r Ba se lin e te st in g 35 °C 45 °C 4° C Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) Lo t 1 (n =4 ) Lo t 2 (n =4 ) No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid No . po sit iv e No . in va lid Pf a nd P an AB ON M al ar ia P an /P .f. R ap id T es t D ev ic e IM A- B4 02 AB ON B io ph ar m (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 BI ON OT E M AL AR IA P .f. & P an A g Ra pi d Te st K it RG 19 -0 8 Bi on ot e, In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia /P re gn an cy C om bo (p LD H /H RP 2/ H CG ) G O2 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia p LD H 3 L in e Te st G O1 21 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Ca re St ar t™ M al ar ia S cr ee n G O2 31 Ac ce ss B io , I N C. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia C om bo VB 11 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Cl ea rv ie w ® M al ar ia D ua l T es t D ev ic e VB 20 Vi si on B io te ch (P ty ) L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P f) Ca ss et te M PN FW BC 10 07 .4 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia C om bo M L0 2 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IC T Di ag no st ic s M al ar ia D ua l M L0 3 IC T Di ag no st ic s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 IM M U N OQ U IC K CO N TA CT M AL AR IA + 4 05 25 K2 5 Bi os yn ex 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 3. 0 M al ar ia P an T es t M AL -W 23 N -0 01 Di m a • Ge se lls ch af t f ür D ia gn os tik a m bH 0. 0 0. 0 2. 0 0. 0 1. 0 0. 0 2. 0 0. 0 2. 0 0. 0 4. 0 0. 0 2. 0 0. 0 2. 0 0. 0 M al ar ia p f ( H RP II ) / (P AN -p LD H ) A nt ig en De te ct io n Te st D ev ic e M FV -1 24 R AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al ar ia p f ( pL DH ) / P AN -p LD H T es t D ev ic e M FV -1 24 AZ OG , I nc . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 M al as ca n™ D ev ic e - Ra pi d te st fo r M al ar ia P f/ Pa n 50 40 20 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pa n Ag RM AP 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 N an oS ig n M al ar ia P f/ Pv A g - RM AD 10 Bi ol an d, L td 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On e St ep M al ar ia P .f/ Pa n Te st W 56 -C G ua ng zh ou W on df o Bi ot ec h Co . L td . 0. 0 1. 0 1. 0 0. 0 0. 0 1. 0 0. 0 1. 0 4. 0 0. 0 4. 0 0. 0 0. 0 0. 0 0. 0 0. 0 On Si te P f/ Pa n M al ar ia A g Ra pi d Te st R0 11 3C CT K Bi ot ec h, In c. 0. 0 0. 0 0. 0 0. 0 3. 0 0. 0 3. 0 0. 0 3. 0 0. 0 3. 0 0. 0 1. 0 0. 0 0. 0 0. 0 Op tiM AL -I T 71 00 24 Di am ed - A D iv is io n of B io -R ad 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pa ra sc re en ™ D ev ic e - Ra pi d te st fo r M al ar ia P an /P f 50 31 00 25 Ze ph yr B io m ed ic al S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g P. f/ Pa n 05 FK 60 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 SD B IO LI N E M al ar ia A g 05 FK 40 St an da rd D ia gn os tic s In c. 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Su re st ep ™ E as y M al ar ia P f/ Pa n Ra pi d Te st D ev ic e IM A- T4 02 AC ON B io te ch (H an gz ho u) C o. L td . 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf , P an a nd P v Co re ™ M al ar ia P an /P v/ Pf M AL -1 90 02 6 Co re D ia gn os tic s 0. 0 0. 0 0. 0 0. 0 0. 0 1. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 di ag no st ic ks M AL AR IA (P an /P v/ Pf ) C as se tt e M PN VF C1 00 7. 5 SS A Di ag no st ic s & B io te ch S ys te m s 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 0. 0 Pf : P la sm od iu m fa lc ip ar um Pv : P la sm od iu m v iv ax pa n: P la sm od iu m sp ec ie s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)104 annex 5a: selection of an appropriate rdt Step 1.1 Define setting of use What ? target parasite species and antigena Pf or mixed Pf/non-Pf infections: - HRP2 - pLDH-Pf Pf or non-Pf infectionsb: - HRP2, aldolase ; HRP2, pLDH-pan - HRP2, pLDH-Pv; HRP2, pLDH-Pvom - HRP2, pLDH-pan; pLDH-Pv - pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv - pLDH-Pf, pLDH-P vom P.vivax, only: - aldolase - pLDH-pan - pLDH-Pv **Pf with absent HRP2 – DO NOT USE HRP2 based RDTsc Where ? Exposure high temperature eg. tropical environment OR Temperature controlled environment, including during transport and storage Who? Laboratory personnel OR Health workers outside of laboratories Step 1.2 Review RDT performance WHO RDT Product Testing resultsd and apply WHO recommended RDT selection criteriae - Panel Detection Score (PDS) - False Positivity Rate (FPR) - Invalid Rate (IR) - Ease of use - Thermal stability - Ease of use Sensitivity and specificity based on quality field studies in relevant populations Generate RDT short list Step 1.3 Apply national guidelines and experience in use of RDTs National malaria treatment guidelines In-country experience: ease of use assessments (Annex 5b); availability of training materials Step 1.4 Other considerations - Price - Supplier’s: production capacity, lead times, heat stability data - Delivery schedules (eg. staggered deliveries), box size, shelf life - Registration requirements of a national regulatory authorities - Product lot testing results - Overall budget requirements (Annex 6) a Pf only or mixed Pf/non Pf infections: Most area of sub-Saharan Africa and lowland Papua New Guinea; : Pf and non-Pf invfections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere b Tests with a falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed falciparum infections. Distinguishing falciparum from mixed falciparum-vivax infections only becomes important if a full course of primaquine is routinely given for infections due to P. vivax. This must be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum and P. vivax-specific lines. Inclusion of further test lines to detect these (eg. Pf- Pv-pan) increases complexity of test interpretation. A programme should prioritize these various advantages and dis-advantages according to local conditions in the initial stage of making procurement decisions. c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified in parts of South America (Gamboa D et al. PLoS ONE 5(1):e8091.doi:10.1371/journal.pone.000809) d Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 1(2008); Round 2 (2009); Round 3 (2010); FIND Malaria RDT Product Testing: Interactive Guide - http://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/ e WHO RDT procurement criteria : http://www.who.int/malaria/diagnosis_treatment/diagnosis/RDT_selection_criteria.pdf (accessed 6 September, 2011) For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing product variations, see the “Good Practices for selecting and procuring rapid diagnostic tests for malaria” (6) an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 105 annex 5b: rdt format review and ease of use assessment Obtain samples of each malaria RDT under consideration (at least 1 box packaged as intended for final delivery) Obtain negative blood samples, and where readily accessible, parasite positive blood samples for testing against RDTs. The purpose of an evaluation on a limited number of tests is to assess aspects of ease-of-use and to screen for major test anomalies, as described in the table below, and not to assess diagnostic accuracy. Device and components of kit Features to look for in product review and ease-of-use assessment Test strip • Good clearance of blood by time of reading • Even flow of blood up strip Test lines • ‘ghost line’ – sometimes a faint line can be seen before the test is used • False-positives: blood products stick to line, giving an impression of a positive result • Very thin or incomplete lines in positive cases, or spreading of line colour along strip (‘leaching’) Control lines • As with test lines RDT buffer • Variable drop size • Leakage from bottles • Overflow of buffer from well on cassette when correct number of drops are applied. Structural issues Shifting of strips inside cassette Blood transfer device • Blood safety features • Ease-of-use Other QC issues a) Not enough buffer provided b) No test tubes provided c) Cassette is damaged/Missing parts d) Cassette has no identifiers e) Box is missing instructions/Instructions aren’t clear f) Condition of boxes – those without natural disaster excuses g) Tests aren’t always “easy open” Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)106 As parasite-based diagnosis is introduced at smaller clinics and village level for case management, a large number of challenges arise not only in logistical administration but also in managing the health-seeking and health-providing behaviour of patients and health workers. These can be addressed by a systematic approach to planning, imple- mentation, monitoring and evaluation of the diagnostic programme; a process that must commence well before RDTs are procured. Examples of widescale successful introduction of malaria RDTs are now in existence in various national programmes (26). The following information is derived from existing WHO documents addressing this area.27 A malaria RDT Implementation manual to guide national programmes in this area is nearing completion and will be accessible at www.wpro.who.int/sites/rdt and www.finddiagnostics.org/ resource-centre/reports_brochures/. Many health workers and communities will have been taught that “fever equals malaria unless proven otherwise”. Introducing RDTs will demonstrate that this is not the case. To have an impact on anti-malarial diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients alike, that is, they must be as good or better than those relied on previously. A health worker will also need a good alternative to anti-malarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place (detailed elsewhere on this website). There must be satisfactory education of health workers, and widespread community sensitization. Knowledge of other causes of fever will be necessary to develop appropriate management algorithms for parasite-negative cases. 27 Developed by WHO Regional Office for the Western Pacific and the WHO Global Malaria Programme, with support from the Uganda Ministry of Health (National Malaria Control Programme), Management Sciences for Health (MSH), and other partners. At the national level, regulatory requirements may need to be developed to control the importation and use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, may need to be developed. If changing from a different product or mode of diagnosis, an adequate phase-out plan for this must also be developed. This requires a clear strategic plan to be developed well in advance of RDT introduction, with a clear timeline to ensure that the various components of the RDT programme are in place at the right time. A focal person, or persons, will be needed to coordinate the overall implementation plan and ensure that the various agencies that may be involved understand the process and their particular roles. To achieve this, funding for the programme must include a significant component for planning and coordination, sensitization/IEC, training, quality assurance, monitoring and supervision, and logistics, in addition to procurement. Without this, much of the funds expended on RDTs may be wasted, and a loss of confidence in RDT-based diagnosis may hinder the process of strengthening appropriate malaria case management. An example of a national implementation plan is shown on the following pages. This will need to be modified consider- ably for each programme, preferably through a collaborative process involving all the major agencies concerned in its implementation. Budgeting for all the components of the programme at the outset is vital. An example of components to be considered in an overall budget is shown in Figure A6.1. annex 6: introducing rdt-based malaria diagnosis into national programmes an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 107 Summary of introduction plan (see following page) Program planning and management Identify key stakeholders, and secure commitment for introduction of RDTs Establish working group and develop terms of reference Identify specific focal person(s) responsible for day to day oversight of the implementation plan Develop a timeline, scope, and budget for implementation Identify human and other resource needs, and a strategy for accessing them Review and update, if needed, case-management algorithms for malaria and other causes of febrile illness Policy and regulatory issues Develop appropriate regulatory documents if required Register RDT products Procurement of RDTs Develop product specifications and packaging requirements Develop product short-list Conduct quantification (estimation of needs) Procure RDTs Procure sharps boxes, gloves etc. Logistics Develop distribution plan Train logistics and storage personnel in handling and distribution of RDTs Implement a system for data collection and information flows Arrange for appropriate transport and storage Review and strengthen inventory management, as needed Develop a plan for discontinuation and disposal of other diagnostic supplies, if appropriate Quality Assurance Develop mechanisms for assessing samples at a national level (lot-testing), and regular (and random) testing at the level of use (e.g. microscopy-sentinel sites) Implement post-marketing surveillance Training and communication Develop appropriate training and supervision materials Train health workers in case management and managing commodities Train in RDT use Develop and implement a program for community education/ sensitization Monitoring and Evaluation Implement effective supervision and monitoring Strengthen recording and reporting procedures Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)108 Re co m m en de d se qu en ce o f ac ti vi tie s fo r im pl em en ta tio n of R DT -b as ed d ia gn os is in a n at io na l m al ar ia p ro gr am m e an d th e re la ti ve t im e al lo tm en t. a RD T IM PL EM EN TA TI O N T IM EL IN E Pr og ra m m e pl an ni ng a nd m an ag em en t Ap po in t m al ar ia d ia gn os is co or di na to r( s) Po lic y re co m m en da tio ns W rit te n M oH e nd or es m en t Gu id el in es W rit te n M oH e nd or se m en t Ca se m an ag em en t of f ev er o f un kn ow n or ig in Ca se m an ag em en t of m al ar ia RD T (a nd m ic ro sc op y) q ua lit y as su ra nc e RD T tr an sp or t an d st or ag e De ci de d ist ric ts f or in iti al / ph as ed im pl em en ta tio n Fe ve r m an ag em en t al go rit hm W rit te n M oH e nd or se m en t De te rm in e/ de sig na te t ra ns po rt a nd s to ra ge m et ho ds Re gu la to ry is su es W rit e Re g. A ut ho rit y an d N M CP r ol es W rit e re gi st ra tio n cr ite ria Re gi st er RD T pr oc ur em en t an d lo gi st ic s Se le ct 3 -4 p ro du ct s Sa m pl es f or e as e- of -u se a ss es sm en t Fi na l d ec isi on o n RD T N eg ot ia te s pe ci fic at io ns w ith m an uf ac tu re r Pr oc ur em en t De pe nd en t on r eg is tr at io n pr oc es s Re ce iv e fir st b at ch (o f st ag ge re d de liv er y) La te r ba tc h Di st rib ut io n to f ie ld Pr oc ur e gl ov es Pr oc ur e sh ar ps b ox es Pr oc ur e ot he r as so ci at ed m at er ia ls Q ua lit y As su ra nc e W rit e se nt in el s ite S O P De te rm in e se nt in el s ite s Se t- up s en tin el s ite s Se t up M on ito rin g Lo t- te st in g Po st -m ar ke tin g su rv ei lla nc e Tr ai ni ng a nd c om m un ic at io n Co nd uc t ca se m an ag em en t tr ai ni ng f or f ev er M ay b e co nd uc te d ea rli er , o r al re ad y in p la ce M od ify R DT in st ru ct io ns a nd t ra in in g m an ua l Fi el d- te st m od fie d tr ai ni ng /in st ru ct io ns Tr ai ni ng o f tr ai ne rs Co m m un ity s en sit iz at io n Ge ne ra l h ea lth c ar e pr ov id er s ed uc at io n M on ito rin g an d ev al ua tio n De ve lo p ap pr op ria te r ec or d fo rm s an d pr oc ed ur es Re gu la r su pe rv isi on Po st -i nt ro du ct io n pr og ra m m e re vi ew a t im e re qu ir em en ts w ill v ar y be tw ee n pr og ra m m es an n e Xe s Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 109 Figure A6.1 Example malaria RDT implementation budget Below is an example of major components of a programme budget to be considered when introducing RDTs into a malaria programme. Without adequate provision for each of these factors, it is likely that an RDT-based diagnostics programme will fail to achieve its goals. These components should therefore be addressed in proposals for programme funding, or provisions should be made for them in collaborating programmes. Monitoring accuracy in field Training and supervision Testing and laboratory monitoring Training, drugs / supplies for non-malarial fever Community education Procurement of gloves, sharps disposal containers etc. Procurement of RDTs Transport and storage Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)110 notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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M ala ria R ap id D iag no st ic Te st Pe rfo rm an ce Re su lts o f W HO p ro du ct te st in g of m ala ria R DT s: Ro un d 3 (2 01 0- 20 11 ) TDR/World Health Organization 20, Avenue Appia 1211 Geneva 27 Switzerland Fax: (+41) 22 791 48 54 tdr@who.int www.who.int/tdr FIND Avenue de Budé 16 1202 Geneva Switzerland Fax: (+41) 22 710 05 99 info@finddiagnostics.org www.finddiagnostics.org ISBN 978 92 4 150256 6