Target product profile to detect prepatent Dracunculus medinensis infections in animals

Target product profile to detect prepatent Dracunculus medinensis infections in animals Target product profile to detect prepatent Dracunculus medinensis infections in animals Target product profile to detect prepatent Dracunculus medinensis infections in animals ISBN 978-92-4-009080-4 (electronic version) ISBN 978-92-4-009081-1 (print version) © World Health Organization 2024 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. iii Contents Acknowledgements iv 1. Epidemiology 1 2. Available diagnostic tools and their limitations 1 3. Need for novel target product profiles 1 4. Diagnostic Technical Advisory Group and methodology 2 References 3 Annex 1. Characteristics of a target product profile to detect prepatent Dracunculus medinensis infections in animals 4 Annex 2. Objectives and use case 12 iv Acknowledgements This target product profile (TPP) was developed under the overall direction of the World Health Organization Global Neglected Tropical Diseases Programme (WHO/NTD) following the standard WHO procedure for TPP development. Work was guided by Dieudonné P. Sankara (WHO/NTD), supported by Junerlyn Farah Agua (WHO/ NTD), Camilla Ducker (Consultant, WHO/NTD), and Andrew Seidu Korkor (WHO Regional Office for Africa). Special thanks are due to the members of the WHO Diagnostic Technical Advisory Group (DTAG) subgroup on TPPs for dracunculiasis (Guinea worm) eradication (referred to in the figure below as the “Scientific TPP development group”): Rosanna W. Peeling (International Diagnostics Centre, London School of Hygiene & Tropical Medicine, London, United Kingdom of Great Britain and Northern Ireland; Chair of the DTAG subgroup); Sarah Cleveland (Institute of Biodiversity, Animal Health and Comparative Medicine, College of Medical, Veterinary and Life Sciences, University of Glasgow, United Kingdom of Great Britain and Northern Ireland); Laura B. Goodman (Cornell University College of Veterinary Medicine, Baker Institute for Animal Health, Ithaca (NY), United States of America); Richard Ngondolo (Institut de Recherche en Elevage pour le Développement, N’Djamena, Chad); Adam J. Weiss (The Carter Center, Atlanta (GA), United States of America); Robbie McDonald (Environment and Sustainability Institute, University of Exeter, Penryn, United Kingdom of Great Britain and Northern Ireland); Sadi Moussa (The Carter Center, Bamako, Mali); Tadesse Zerihun (The Carter Center, Addis Ababa, Ethiopia); Matt Erdman (United States Animal and Plant Health Inspection Service, Riverdale (MD), United States of America); and Jerry Saliky (Oklahoma Animal Disease Diagnostic Laboratory, Oklahoma State University College of Veterinary Medicine, Stillwater (OK), United States of America). Christopher Hanna (Consultant, Bill & Melinda Gates Foundation, Seattle (WA), United States of America) participated as an observer. Vitaliano Cama, Diana Martin and Sharon Roy (United States Centers for Disease Control, Atlanta (GA), United States of America), Maryann Delea (The Carter Center, Atlanta (GA), United States of America), Patrick Lammie (NTD Support Center, Task Force for Global Health, Decatur (GA), United States of America) and Marco Biamonte (Drugs and Diagnostics for Tropical Diseases, San Diego (CA), United States of America) reviewed the document. WHO also acknowledges Jordan Tappero (Bill & Melinda Gates Foundation, Seattle (WA), United States of America) for his dedication and unwavering support throughout the process, and to the members of the dracunculiasis eradication community and the public who provided feedback on the draft document during the public consultation. Daniel Argaw Dagne (WHO/NTD) gave support and input on the development process. The development of this TPP was financially supported by the Bill & Melinda Gates Foundation. Declarations of interest Declarations of interest were submitted by all members of the DTAG subgroup for review and assessment by WHO/NTD. None of the members declared a conflict of interest. 11. Epidemiology Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode Dracunculus medinensis (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal (1). The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022 (2). To date, however, there are no validated tests to diagnose pre-patent D. medinensis infection. 2. Available diagnostic tools and their limitations A critical part of any eradication programme involves reliably identifying infected and exposed definitive hosts. Historically, the diagnosis of Guinea-worm disease was clinical in nature and occurred via visually confirming the emergence of a white worm, roughly 10–14 months after the acquisition of infection. Currently, the definitive diagnosis involves either microscopy or, if necessary, conventional polymerase chain reaction applied to a DNA preparation from emergent worm fragments. A diagnostic tool capable of confirming active infection with D. medinensis many months before the emergence of a Guinea worm would represent a leap forward for the global dracunculiasis eradication campaign. 3. Need for novel target product profiles Diagnostic modalities and platforms that can be easily used in locations where Guinea worm is observed or suspected among animal hosts are needed for the early diagnosis of prepatent Guinea worm infection to enhance follow-up and containment of infected hosts. Through the early detection and containment of Guinea worm-infected hosts, these diagnostics would ultimately serve to decrease the amount of parasite available in the environment for onward transmission. Diagnostic tools capable of detecting prepatent infection would enhance disease surveillance and provide national programme staff with additional data to identify transmission hot spots before the emergence of worms in affected areas. Diagnostic tools that can identify hosts with prepatent infection would further inform the targeting and implementation of disease-preventive interventions such as tethering of domesticated animal hosts and treating surface water sources with larvicide. Guinea worm diagnostic tools that could detect prepatent infection would also generate evidence of the absence of Guinea worm infection in definitive hosts, which could help certify countries as free of dracunculiasis transmission and ultimately facilitate the certification of dracunculiasis eradication. 24. Diagnostic Technical Advisory Group and methodology The WHO Neglected Tropical Diseases Programme manages a diverse portfolio of 20 diseases and disease groups, each with its own unique epidemiological, diagnostic and control challenges. In 2019, the WHO Strategic and Technical Advisory Group for Neglected Tropical Diseases recommended the establishment of a Diagnostic Technical Advisory Group (DTAG) to help ensure a consistent approach to identifying and prioritizing diagnostic needs as well as to inform WHO strategies and guidance on the subject. At its first meeting (Geneva, 30–31 October 2019), the DTAG discussed diagnostic priorities as well as how to manage the complexity of supporting the diagnostics agenda across the entirety of the WHO portfolio of NTDs (3). The road map 2021–2030 identified the need for novel diagnostic tools as a priority for investment (4). One of the recommendations was to create a subgroup dedicated to zoonoses, including dracunculiasis, with an initial mandate to define target product profiles (TPPs) for new diagnostics necessary to reach the 2030 road map targets. The subgroup consisted of a variety of relevant content experts, who met online several times in the presence of observers representing donor agencies, major non-profit groups and WHO representatives (from WHO headquarters and the WHO Regional Office for Africa). The priorities of the subgroup were to establish TPPs for tests to support (i) the detection of prepatent D. medinensis infections in animals and (ii) the detection of D. medinensis presence in environmental samples. This TPP was developed following the standard process for TPP development (see Fig.). Version 0.1 of the TPP was produced and posted online for public consultation for 28 days, after which comments were incorporated and discussed with subgroup members, and a version V1.0 was produced. The conclusions and decisions of the subgroup were based on consensus among its members. The characteristics of the TPP are presented in Annex 1, and the objectives and use case in Annex 2. De te rm in e Ne ed fo r T PP Co ns tit ut e Sc ie nt ifi c TP P de ve lo pm en t g ro up Po st V 0. 1 fo r 2 8 da y on lin e pu bl ic co ns ul ta tio n Po st V 1. 0 on w eb sit e De ve lo p 1- pa ge r f or pl an ni ng cl ea re nc e De te rm in e au di en ce ou ts id e W HO Pr od uc e ve rs io n 0. 1 of TP P Di sc us s c om m en ts w ith TP P De v G ro up a nd pr od uc e V1 .0 Up lo ad m et ad at a to W HO P P Di re ct or y Fig. WHO process for establishing new target product profiles 3References 1. World Health Assembly resolution WHA39.21. Elimination of dracunculiasis. Geneva: World Health Organization; 1986 (https://iris.who.int/handle/10665/163182). 2. Dracunculiasis eradication: global surveillance summary, 2022. Wkly Epidemol Rec. 2024; 98(20):205–24 (https://iris.who.int/handle/10665/367924). 3. Report of the first meeting of the WHO diagnostic technical advisory group for neglected tropical diseases: Geneva, Switzerland, 30–31 October 2019. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/331954). 4. Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021–2030. Geneva: World Health Organization; 2020 (https://iris.who.int/handle/10665/338565). 4A nn ex 1 . C ha ra ct er ist ic s o f a ta rg et p ro du ct p ro fil e t o de te ct p re pa te nt D ra cu nc ul us m ed in en sis in fe ct io ns in an im al s O bj /N ee d 1. P ro du ct u se su m m ar y M in im um Id ea l Ba ck gr ou nd , a nn ot at io n re re qu ire m en t r isk , e tc . O bj ,3 ,5 ,7 1. 1 In te nd ed u se A n in v itr o la bo ra to ry -b as ed te st fo r th e de te ct io n of a na ly te sp ec ifi c to D ra cu nc ul us m ed in en sis in fe ct io n in an im al s. Te st o ut pu t w ill in fo rm th e st at us o f t ra ns m iss io n ac tiv ity a nd al lo w m on ito ri ng o f i nf ec tio ns to w ar ds ce rt ifi ca tio n of e lim in at io n. A n in v itr o po in t- of -c ar e/ -d ec isi on te st fo r t he d et ec tio n of a na ly te sp ec ifi c to D . m ed in en sis in fe ct io n in a ni m al s. Te st o ut pu t w ill in fo rm th e st at us of tr an sm iss io n ac tiv ity a nd a llo w m on ito ri ng o f i nf ec tio ns to w ar ds ce rt ifi ca tio n of e lim in at io n. Th e di ag no st ic la nd sc ap e fo r D . m ed in en sis d oe s n ot in cl ud e a va lid at ed p oi nt -o f- ca re /- de ci sio n te st o pt io n. W hi le so m e la bo ra to ry -b as ed te st s h av e sh ow n pr om isi ng re su lts a nd fi el d- ba se d co lle ct io n of sp ec im en s c an b e co nd uc te d fo r t ra ns po rt to th es e la bo ra to ri es , t he d ev el op m en t o f a fu ll po in t- of -c ar e/ - de ci sio n te st th at a lso m ee ts th e re qu ire m en t f or m in im al tr ai ni ng re qu ire m en ts w ill re qu ire si gn ifi ca nt ti m e an d eff or t g oi ng fo rw ar d; h en ce , t hi s i s a h ig h- ri sk re qu ire m en t. If a no th er te st ot he r t ha n a po in t- of -c ar e te st is a va ila bl e, sa m pl in g (in cl ud in g de ve lo pm en t o f s am pl in g m et ho ds ) s ho ul d no t b e de la ye d w hi le aw ai tin g a po in t- of -c ar e te st . O bj ,5 ,6 1. 2 Ta rg et ed p op u- la tio n A ll ag es a nd g en de rs o f t ar ge te d do gs an d ca ts in th e aff ec te d ge og ra ph y. A ll ag es a nd g en de rs o f t ar ge te d do gs , ca ts a nd b ab oo ns in th e aff ec te d ge og ra ph y. N O TE : U se o f t he te st fo r b ab oo ns is d on e “a t r isk ” s in ce th e m od el lin g of p er fo rm an ce re qu ire m en ts fo r b ab oo ns is n ot a s w el l u nd er st oo d. 1, 2, 4, 7, 10 1. 3 Lo w es t i nf ra - st ru ct ur e le ve l Fo r a la bo ra to ry -b as ed te st , t es ts c an be p er fo rm ed in a c en tr al o r p er ip he ra l te st in g fa ci lit y. Fo r a p oi nt -o f- ca re /- de ci sio n te st , t es ts ca n be p er fo rm ed u nd er “z er o- in fr a- st ru ct ur e” c on di tio ns in cl ud in g bu t no t l im ite d to h ou se ho ld s, co m m un ity he al th c en tr es , a nd p ot en tia lly o ut do or co nd iti on s. “Z er o in fr as tr uc tu re ” c on di tio ns a re th os e w he re n o pr io r r e- qu ire m en ts m us t b e fu lfi lle d fo r p ro pe r o pe ra tio n of th e te st . 1, 2, 4, 7, 12 1. 4 Lo w es t l ev el us er Fo r a la bo ra to ry -b as ed te st , t he te st w ill be p er fo rm ed b y tr ai ne d la bo ra to ry te ch ni ci an s. Fo r p oi nt -o f- ca re /- de ci sio n te st s, th e te st w ill b e pe rf or m ed b y he al th p er - so nn el , c om m un ity h ea lth w or ke rs a nd co m m un ity v ol un te er s. 1, 2, 4, 7, 12 1. 5 Tr ai ni ng re - qu ire m en ts Fo r a la bo ra to ry -b as ed te st , l es s t ha n on e w ee k fo r t ra in ed la bo ra to ry te ch - ni ci an s; te st in g jo b ai d/ in st ru ct io ns fo r us e sh ou ld b e m ad e av ai la bl e vi a th e In te rn et fo r d ow nl oa d (i. e. a re p ub lic ly av ai la bl e) . Fo r a p oi nt -o f- ca re /- de ci sio n te st , o ne da y or le ss fo r h ea lth p er so nn el , c om - m un ity h ea lth w or ke rs a nd c om m un ity vo lu nt ee rs ; t es tin g jo b ai d/ in st ru ct io ns fo r u se sh ou ld b e m ad e av ai la bl e vi a th e In te rn et fo r d ow nl oa d (i. e. a re p ub lic ly av ai la bl e) . Th e di ag no st ic la nd sc ap e fo r D . m ed in en sis d oe s n ot in cl ud e a va lid at ed p oi nt -o f- ca re /- de ci sio n te st o pt io n. W hi le so m e la bo - ra to ry -b as ed te st s h av e sh ow n pr om isi ng re su lts a nd fi el d- ba se d co lle ct io n of sp ec im en s c an b e co nd uc te d fo r t ra ns po rt to th es e la bo ra to ri es , t he d ev el op m en t o f a fu ll po in t- of -c ar e/ -d ec isi on te st th at a lso m ee ts th e re qu ire m en t f or m in im al tr ai ni ng re - qu ire m en ts w ill re qu ire si gn ifi ca nt ti m e an d eff or t g oi ng fo rw ar d; he nc e, th is is a hi gh -r isk re qu ire m en t. N O TE : I t i s n ot a re qu ire m en t t o ha ve In te rn et a cc es s t o ob ta in jo b ai ds /in st ru ct io ns fo r u se si nc e th es e m us t b e in cl ud ed w ith th e te st it se lf (p er R eq ui re m en t 4 .5 ), bu t r at he r t ha t j ob a id s/ in - st ru ct io ns fo r u se sh ou ld a lw ay s b e av ai la bl e vi a th e In te rn et . O pe ra to r t ra in in g m us t i nc lu de sp ec im en c ol le ct io n, fo r e xa m pl e w ho le b lo od fr om v en ip un ct ur e co lle ct io n of p er ip he ra l b lo od . 5O bj /N ee d 2. D es ig n M in im um Id ea l A nn ot at io n 1, 2, 4, 7, 12 2. 1 Po rt ab ili ty Fo r a la bo ra to ry -b as ed te st , s pe ci fic po rt ab ili ty a nd tr an sp or t r eq ui re m en ts sh ou ld n ot b e be yo nd th os e as so ci at ed w ith st an da rd la bo ra to ry e qu ip m en t. Fo r a p oi nt -o f- ca re /- de ci sio n te st , hi gh ly p or ta bl e w ith n o sp ec ia liz ed tr an sp or t n ee ds . Fo r “ Id ea l” , “ Po rt ab ili ty ” i m pl ie s t ho se ch ar ac te ris tic s d es cr ib ed in 2 .2 -2 .4 a s w el l a s n o lo ca tio na l l im ita tio ns to w he re th e te st c an be p er fo rm ed . Fo r b ot h “M in im um ” o r “ Id ea l” co nd iti on s, th e te st m ay o r m ay n ot u til iz e m ob ile p ho ne -b as ed te ch no lo gy . Te st in g lo ca tio n to su it pr et ty lo w re so ur ce se tti ng li ke p oi nt o f c ar e. In ad di tio n, a ll sa m pl es co ul d be co lle ct ed a nd te st in g pe rf or m ed al l t og et he r i n on e co nv en ie nt lo ca tio n. W he re th er e is no p oi nt of c ar e te st y et , l ab or at or y- ba se d te st s s ho ul d be u se d if av ai la bl e. M ak in g us e of b ot h po in t- of -c ar e an d la bo ra to ry -b as ed te st s i s a lso fin e as lo ng a s i t b rin gs a dd ed v al ue to th e pr og ra m m e de ci sio ns . 1, 4, 7, 10 ,1 2 2. 2 In st ru m en t/ po w er re qu ire m en t Fo r a la bo ra to ry -b as ed te st , a cc es s t o m ai ns p ow er is a cc ep ta bl e. Fo r a p oi nt -o f- ca re /- de ci sio n te st , s el f- co nt ai ne d ki t o pe ra te s i nd ep en de nt o f an y m ai ns p ow er . 1, 4, 7, 12 2. 3 W at er re qu ire m en t Fo r a la bo ra to ry -b as ed te st , a cc es s t o la bo ra to ry -g ra de w at er is a cc ep ta bl e. Fo r a p oi nt -o f- ca re /- de ci sio n te st , s el f- co nt ai ne d ki t o pe ra te s i nd ep en de nt o f an y w at er su pp ly. 1, 4, 7, 12 2. 4 M ai nt en an ce an d ca lib ra tio n Fo r a la bo ra to ry -b as ed te st , p er io di c m ai nt en an ce a nd c al ib ra tio n of a ny in st ru m en ta tio n m us t b e av ai la bl e in th e co un tr ie s a nd sh ou ld n ot b e ne ed ed m or e fr eq ue nt ly th an o nc e a ye ar . Fo r a p oi nt -o f- ca re /- de ci sio n te st , n o m ai nt en an ce re qu ire d (i. e. d isp os ab le ) an d no c al ib ra tio n re qu ire d. 1, 2, 4, 6, 7, 11 2. 5 Sa m pl e ty pe / co lle ct io n Ve no us b lo od sa m pl e, p er ip he ra l w ho le bl oo d (in cl ud in g ea r p ri ck /p aw p ic k) , dr ie d bl oo d sp ot , s er um . Ve no us b lo od sa m pl e, P er ip he ra l w ho le bl oo d (in cl ud in g ea r p ri ck /p aw p ic k) , al so u sin g dr ie d bl oo d sp ot , s to ol o r ot he r. Sa m pl in g: n ee ds id ea lly to b e ab le to u se sa m pl es th at a re co lle ct ed w ith m in im al in va siv en es s ( e. g. sm al l v ol um es o f ca pi lla ry b lo od ) b ut te st s c ar ri ed o ut u sin g ve no us b lo od sa m pl es ar e al so a cc ep ta bl e. It m ay b e ne ce ss ar y to h av e sp ec ia liz ed tr ai ni ng fo r s am pl e co lle ct io ns . S al iv a sa m pl es ty pe is d is co ur ag ed d ue to th e ri sk o f ra bi es in fe ct io n to th e op er at or s. 1, 2, 4, 7, 11 2. 6 Sa m pl e pr ep ar at io n/ tr an sf er d ev ic e · Sa m pl e pr ep ar at io n sh al l n ot e xc ee d on e pr ep ar at io n st ep p ri or to tr an sf er of th e sa m pl e to th e te st in g de vi ce . · Tr an sf er o f t he sa m pl e vo lu m e to th e te st in g de vi ce sh al l o cc ur b y us e of a pr ed efi ne d an d pr ov id ed si ng le -u se tr an sf er d ev ic e (e .g . i nv er te d cu p, di sp os ab le fi xe d- vo lu m e tr an sf er pi pe t) . · Sa m pl e pr ep ar at io n sh al l n ot e xc ee d tr an sf er o f t he sa m pl e to th e te st in g de vi ce . · Tr an sf er o f t he sa m pl e vo lu m e to th e te st in g de vi ce sh al l o cc ur b y us e of a pr ed efi ne d an d pr ov id ed si ng le -u se tr an sf er d ev ic e (e .g . i nv er te d cu p, di sp os ab le fi xe d- vo lu m e tr an sf er pi pe t) . 1, 2, 4, 6, 7 2. 7 Sa m pl e vo lu m e 1– 10 0 uL 1– 10 0 uL “S am pl e vo lu m e” re pr es en ts th e vo lu m e i nt ro du ce d to th e te st de vi ce it se lf; th e or ig in al co lle ct ed sa m pl e vo lu m e m ay e xc ee d th is vo lu m e lim it, fo r e xa m pl e fo r v en ip un ct ur e bl oo d sp ec im en s. 6O bj ,3 ,5 ,8 ,9 2. 8 Ta rg et a na ly te Bi om ar ke r( s) sp ec ifi c fo r d et ec tio n of pr ep at en t a nd p at en t i nf ec tio ns fr om D . m ed in en sis . Bi om ar ke r( s) sp ec ifi c fo r d et ec tio n an d di ffe re nt ia tio n of in fe ct io n pa te nc y (e .g . pr e- vs -p os t) fr om D . m ed in en sis . A na ly te s b as ed o n an tig en s o r o th er b io m ar ke r t yp es (e .g . s om e nu cl ei c ac id -b as ed m ar ke rs ) w ill p re su m ab ly p ro vi de m or e fa vo ur ab le h al f- lif e ki ne tic s a nd th us e na bl e m or e ac cu ra te de te rm in at io n of a ct iv e in fe ct io n fr om D . m ed in en sis . F or ex am pl e, Ig G -b as ed se ro lo gy b io m ar ke rs m ay p os se ss k in et ic s th at e na bl e de te rm in at io n of p ri or in fe ct io ns fr om D . m ed in en sis th at m ay o r m ay n ot st ill b e ac tiv e, h en ce th ei r h al f- lif e ki ne tic s w ou ld re qu ire e va lu at io n to d et er m in e w he th er th ei r p re se nc e di m in ish es p os t- pa te nc y. D iff er en tia tio n be tw ee n pa te nt a nd pr ep at en t i nf ec tio n re pr es en t t he id ea l r eq ui re m en t. If e xi st in g G ui ne a w or m b io m ar ke rs (e .g . s er ol og y- ba se d, n uc le ic a ci d- ba se d) a re fu rt he r d ev el op ed o r i f n ew b io m ar ke rs a re d is co ve re d an d pr op os ed , t he ir q ua lifi ca tio n an d va lid at io n w ill re qu ire sig ni fic an t t im e an d eff or t g oi ng fo rw ar d. F or th is re as on , t hi s i s a hi gh -r isk re qu ire m en t. 2, 4, 7, 8, 9, 11 ,1 2 2. 9 Ty pe o f a na ly sis Q ua lit at iv e Q ua lit at iv e 1, 4, 7, 9, 12 2. 10 D et ec tio n Fo r l ab or at or y- ba se d te st s, m ay in cl ud e in st ru m en t- ba se d de te ct io n of a si gn al th at p ro vi de s u na m bi gu ou s de te rm in at io n of a q ua lit at iv e m ea su re . Fo r p oi nt -o f- ca re /- de ci sio n te st s, re su lts sh al l b e a hi gh c on tr as t, cl ea r r es ul t fo r t he n ak ed e ye ; i nd oo r a nd o ut do or re ad in g of a si gn al th at p ro vi de s a n un am bi gu ou s q ua lit at iv e re su lt w ith ou t th e ne ed fo r c ol ou r d is cr im in at io n. Fo r b ot h, la bo ra to ry -b as ed a nd p oi nt - of -c ar e te st s: th e te st re su lt is ca pt ur ed th ro ug h di gi ta l c on ne ct iv ity to re le va nt en tit ie s a nd /o r d at ab as es . N O TE : R eq ui re m en t 2 .1 “P or ta bi lit y” st at es th at e ith er la bo ra to ry -b as ed te st s o r p oi nt -o f- ca re /- de ci sio n te st s m ay u se m ob ile p ho ne -b as ed te ch no lo gi es , w hi ch in th is ca se m ay b e us ed to su pp or t s ig na l d et ec tio n. 3, 4, 7, 8, 9, 10 ,1 2 2. 11 Q ua lit y co nt ro l · In te rn al p ro ce ss c on tr ol in di ca to r (e .g . c on tr ol li ne o n an R D T, c on tr ol w el l i n an E LI SA ). · In te rn al p ro ce ss c on tr ol in di ca to r · C ol ou ri m et ri c or o th er in di ca to r to id en tif y ex ce ss iv e he at /h um id ity ex po su re o f t he te st k its . Te st fe at ur es a sa m pl e ad eq ua cy co nt ro l i nd ic at in g ad eq ua te q ua nt ity o f bi ol og ic al m at er ia l b ei ng p re se nt in th e sa m pl e. Fo r f ur th er c on sid er at io n (i. e. b ey on d TP P sc op e) : d efi ni tio n of ho w e nd og en ou s p os iti ve c on tr ol s s ho ul d/ w ou ld b e us ed if th ey ar e to b e in cl ud ed w ith a te st (e .g . w ill th er e be a c om m un ity - w id e qu al ity p an el , c en tr al iz ed re po rt in g of re su lts ?) . 1, 4, 7, 12 2. 12 S up pl ie s ne ed ed A ll re ag en ts a nd su pp lie s i nc lu de d in te st k it, w ith m in im al im po rt re st ri ct io ns (e .g . a ni m al -f re e, re ag en ts fr ee fr om to xi ci ty le ve ls th at tr ig ge r im po rt re st ri ct io ns ). A ll re ag en ts a nd su pp lie s i nc lu de d in te st k it, w ith m in im al im po rt re st ri ct io ns (e .g . a ni m al -f re e, re ag en ts fr ee fr om to xi ci ty le ve ls th at tr ig ge r im po rt re st ri ct io ns ). A ss um ed th at a ll m at er ia ls ar e in cl ud ed , i nc lu di ng sa m pl e co lle ct io n de vi ce s. 1, 2, 4, 7 2. 13 S af et y N or m al u se d oe s n ot c re at e an y ad di tio na l h az ar ds to th e op er at or w he n ob se rv in g U ni ve rs al B lo od S af et y/ Bo dy Fl ui d pr ec au tio ns . N or m al u se d oe s n ot c re at e an y ad di tio na l h az ar ds to th e op er at or w he n ob se rv in g U ni ve rs al B lo od S af et y/ Bo dy Fl ui d pr ec au tio ns . 7O bj /N ee d 3. P er fo rm an ce M in im um Id ea l A nn ot at io n O bj ,3 ,5 ,9 3. 1 Sp ec ie s d iff er - en tia tio n/ de te ct io n D . m ed in en sis D . m ed in en sis O bj ,3 ,5 ,8 ,9 3. 2 D ia gn os tic /c lin - ic al se ns iti vi ty 80 % > 90 % Te st p er fo rm an ce m od el lin g w as c on du ct ed to e va lu at e th e im pa ct of te st se ns iti vi ty a nd sp ec ifi ci ty o n G ui ne a w or m e lim in at io n w ith in d og p op ul at io ns , w he re “e lim in at io n” w as d efi ne d as th e pe rc en ta ge o f d og in fe ct io ns a fte r 5 y ea rs o f i nt er ve nt io n go in g to ze ro . Th er e ar e va ri ab le s o ut sid e of te st se ns iti vi ty a nd sp ec i- fic ity th at m us t a lso b e ta ke n in to c on sid er at io n, w hi ch in cl ud e do g ow ne r b eh av io ur s ( e. g. p ro ba bi lit y of te th er in g, d ur at io n of te th er in g, le ve ls of a ba te a pp lic at io n/ pe rc en ta ge o f b od ie s o f w at er tr ea te d, a s w el l a s t he te st in g st ra te gy a pp lie d [e .g . p er ce nt ag e of do gs te st ed , s ys te m at ic -v s- ra nd om sa m pl in g, e tc .]) . Ba se d on th e m od el s d ev el op ed , t he fo llo w in g m in im um te st in g co nd iti on s a nd te th er in g be ha vi ou rs w ill le ad to e lim in at io n w ith in 5 y ea rs fo r t he “M in im um ” a nd “I de al ” S e an d Sp te st re qu ire m en ts sh ow n. FO R M IN IM U M S e an d Sp : 90 -d ay te th er in g re qu ire s 1 00 % o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty 18 0- da y te th er in g re qu ire s 5 0% o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty 36 0- da y te th er in g re qu ire s 2 5% o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty FO R ID EA L Se a nd S p: 90 -d ay te th er in g re qu ire s 1 00 % o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty 18 0- da y te th er in g re qu ire s 3 3% o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty 36 0- da y te th er in g re qu ire s 2 0% o f d og s t es te d m on th ly a nd 5 0% da ily te th er in g pr ob ab ili ty (N O TE : I n al l c as es , i t i s a ss um ed a g iv en p op ul at io n’s w at er so ur ce s a re su bj ec te d to m in im um te m ep ho s ( A ba te ) t re at m en t of 5 0% . It is al so a ss um ed th at te st in g oc cu rs in a sy st em at ic , no n- ra nd om m an ne r w he re by d og s a re d iv id ed in to c oh or ts a nd on e co ho rt is te st ed e ac h m on th (e .g . o ne c oh or t 1 00 % o f d og s te st ed m on th ly, tw o co ho rt s 5 0% o f d og s t es te d m on th ly, th re e co ho rt s 3 3% o f d og s t es te d m on th ly ). C er tifi ca tio n w ill d ra w o n m ul tip le d iff er en t t yp es o f e vi de nc e an d lin es o f e vi de nc e. C er ti- fic at io n pr oc es s w ill c on sid er th e se ns iti vi ty a nd sp ec ifi ci ty o f t he su rv ei lla nc e sy st em o ve ra ll. Th us , f or a p ro ba bi lis tic a ss es sm en t o f re la tiv e ris k, p ot en tia lly re la te d to a n as se ss m en t o f t he p er fo r- m an ce o f i nt er ve nt io ns m ea su re a im ed a t s to pp in g tr an sm iss io n of d ra cu nc ul ia sis , s en sit iv iti es lo w er th an th os e sp ec ifi ed c ou ld st ill b e hi gh ly in fo rm at iv e. O bj ,3 ,5 ,8 ,9 3. 3 D ia gn os tic /c lin - ic al sp ec ifi ci ty (s en - sit iv ity a nd sp ec i- fic ity re qu ire m en ts ca n be a ch ie ve d by tw o te st s u se d in co m bi na tio n or in se qu en ce ) 90 % > 95 % 81, 7, 11 3. 4 Ti m e to re su lts ≤ 2 w ee ks fr om sp ec im en c ol le ct io n to te st re su lt; if p oi nt -o f- ca re te st is u se d, ≤ 2 ho ur s f ro m sa m pl in g to re su lt. ≤ 2 da ys fr om sp ec im en c ol le ct io n to te st re su lt; if p oi nt -o f- ca re te st , ≤ 1 0 m in fr om sa m pl in g to re su lt. Th e di ag no st ic la nd sc ap e fo r G ui ne a w or m d oe s n ot in cl ud e a va lid at ed p oi nt -o f- ca re /- de ci sio n te st o pt io n. W hi le so m e la bo ra to ry -b as ed te st s h av e sh ow n pr om isi ng re su lts a nd fi el d- ba se d co lle ct io n of sp ec im en s c on du ct ed fo r t ra ns po rt to th es e la bo ra to ri es , f or im m ed ia te d ec isi on -m ak in g an d re sp on se , a po in t- of -c ar e te st is th e id ea l a nd p re fe rr ed o pt io n. 1, 7, 8, 9 3. 5 Re su lt st ab ili ty D ev el op ed te st re su lt re m ai ns st ab le fo r 0. 5 ho ur . D ev el op ed te st re su lt re m ai ns st ab le fo r 24 h ou rs o r p ro vi de c ap ac ity to d ig ita lly up lo ad te st re su lts (e .g . t hr ou gh a m ob ile p ho ne a pp lic at io n) . · A bi lit y to in te rp re t fi na l t es t r es ul ts in a m an ne r n ot c on st ra in ed by ti m ed st ep s h el ps g re at ly in re so ur ce -c on st ra in ed se tti ng s. · N O TE : H av in g re m ot e co nn ec tiv ity fo r t ra ns fe r o f p oi nt -o f- ca re an d la bo ra to ry -b as ed te st re su lts w ou ld p ro vi de c en tr al iz ed d at a an al ys is (e .g . f or p ro gr am m at ic e va lu at io ns , t o su pp or t c lin ic al st ud ie s) a s w el l a s e na bl in g lo ng -t er m “r es ul t s ta bi lit y” (v ia di gi ta l s to ra ge ) o f t es t r es ul ts . 1, 7, 11 3. 6 Th ro ug hp ut Fo r l ab or at or y- ba se d te st s, ≥ 40 te st s pe r d ay p er te st er . Fo r p oi nt -o f- ca re /- de ci sio n te st s, ≥ 10 te st s p er h ou r p er te st er . · “Th ro ug hp ut ” r ep re se nt s h ow m an y te st s c an b e ru n w ith in a n ho ur /d ay b y on e pe rs on a nd is se pa ra te fr om th e tim e to re su lts . · N O TE : Th es e th ro ug hp ut re qu ire m en ts d o no t i nf er th at te st in g m us t b e ba tc he d in a ll ci rc um st an ce s. A s j us t o ne e xa m pl e, an E LI SA -b as ed te st sh ou ld n ot re qu ire th e ru nn in g of a ll 96 w el ls w ith in a p la te , s o de sig ns sh ou ld c on sid er fl ex ib ili ty w he n ru nn in g te st s ( e. g. h av in g 8- w el l s tr ip s a s p ar t o f a 9 6- w el l p la te de sig n) . 91, 4, 7, 10 3. 7 Ta rg et sh el f- lif e/ st ab ili ty 6 m on th s, 8 °C to n eg at iv e 70 °C ≥ 24 m on th s, 4– 40 °C , 7 5% re la tiv e hu m id ity ; t em pe ra tu re e xc ur sio n/ pr ol on ge d de vi at io n of 5 0 °C fo r 2 w ee ks is a cc ep ta bl e. · Sh el f- lif e/ st ab ili ty re qu ire m en ts re la te to te st k its (i .e . co ns um ab le s, w he th er p oi nt -o f- ca re te st s o r s pe ci m en co lle ct io n ki ts fo r s ub se qu en t l ab or at or y- ba se d te st in g) th at a re us ed in th e fi eld . · C on su m ab le s u se d in a la bo ra to ry fo r l ab or at or y- ba se d te st in g pr oc ed ur es m ay re qu ire re fr ig er at io n (e .g . a t 4 °C fo r t he sa m e du ra tio ns sh ow n in “M in im um ” a nd “I de al ”) . S om e of th e m ol ec ul ar te st in g re ag en ts m ay re qu ire c ol d te m pe ra tu re st or ag e an d sh ip pi ng , a nd in lo ca tio ns w he re P C R is cu rr en tly in p la ce , r eq ui re m en ts fo r s uc h st or ag e co nd iti on s ar e no t c au sin g an a dd iti on al h ur dl e to im pl em en ta tio n. 1, 4, 7, 9, 11 3. 8 Ea se o f u se Fo r l ab or at or y- ba se d te st s, nu m be r o f st ep s a nd c om pl ex ity o f t es t p ro ce du re sh ou ld b e su ch th at a la bo ra to ry te ch ni ci an w ho re ce iv ed a pp ro pr ia te tr ai ni ng o n th e te st p ro ce du re (s ee 1. 5) w ill b e ab le to re pe at ed ly a nd su cc es sf ul ly p er fo rm th e te st b y fo llo w in g su cc in ct IF U s. Te st c om pl ex ity al lo w s f or th e IF U to c ap tu re th e pr oc ed ur e in d ia gr am s, pi ct ur es a nd flo w c ha rt s t o ill us tr at e m et ho d an d re su lts in te rp re ta tio n. M us t b e ab le to u se in a n un pr ot ec te d an d po te nt ia lly h ar sh e xt er na l en vi ro nm en t ( e. g. h ig h te m pe ra tu re , hi gh h um id ity [s ee R eq ui re m en t 3 .1 0] ). IF U s s ho ul d in cl ud e di ag ra m o f m et ho d an d re su lts in te rp re ta tio n; fo r p oi nt - of -c ar e fie ld u se , p ro ce du re st ep s c an be a de qu at el y de sc ri be d on a (“ qu ic k gu id e” st yl e) c he ck -li st /c ha rt . M us t be a bl e to u se in a n un pr ot ec te d an d po te nt ia lly h ar sh e xt er na l e nv iro nm en t (e .g . h ig h te m pe ra tu re , h ig h hu m id ity [s ee R eq ui re m en t 3 .1 0] ). Te st c om pl ex ity is n ot n ec es sa ri ly d es cr ib ed b y th e nu m be r o f pr oc ed ur al o r t im ed st ep s, bu t r at he r b y th e re qu ire d ex te nt a nd co m pl ex ity o f t he IF U to su ffi ci en tly d es cr ib e th e pr oc ed ur e. In so m e in st an ce s, ap pr op ri at e ki tti ng a nd p ac ki ng p ar tit io ns m ay al lo w to m in im iz e th e vo lu m e an d co st o f c ol d sh ip pi ng . 1, 3, 4, 7, 8, 9 3. 9 Ea se o f r es ul ts in te rp re ta tio n Fo r l ab or at or y- ba se d te st s, a de fin iti ve ly in te rp re te d re su lt is ac hi ev ed b y a su ita bl e in st ru m en t t ha t m ee ts re qu ire m en ts d efi ne d in 2 .1 0 “M in im um ”. Fo r p oi nt -o f- ca re te st s, a de fin iti ve ly in te rp re te d re su lt is ac hi ev ed b y m ee tin g re qu ire m en ts d efi ne d in 2 .1 0 “I de al ”. 1, 4, 7, 8, 10 ,1 2 3. 10 O pe ra tin g te m pe ra tu re 15 –2 3 °C , 7 5% re la tiv e hu m id ity 15 –4 0 °C , 9 9% re la tiv e hu m id ity 10 O bj /N ee d 4. P ro du ct co nfi gu ra tio n M in im um Id ea l A nn ot at io n 1, 10 ,1 2 4. 1 Sh ip pi ng co nd iti on s Fo r l ab or at or y- ba se d te st s, co nf or m an ce to a pp lic ab le re qu ire m en ts o f A ST M D 41 69 -0 5 an d IS O 1 16 07 -1 :2 00 6 (o r eq ui va le nt ); co ld -c ha in sh ip pi ng a t 4 °C (i. e. c om m on re fr ig er at io n) o r i n fr oz en st at e fo r s om e co m po ne nt s i s a cc ep ta bl e fo r a ny te st c om po ne nt s/ co ns um ab le s us ed in th e la bo ra to ry . Fo r p oi nt -o f- ca re /- de ci sio n te st s, co nf or m an ce to a pp lic ab le re qu ire m en ts of A ST M D 41 69 -0 5 an d IS O 1 16 07 - 1: 20 06 (o r e qu iv al en t) ; n o co ld -c ha in sh ip pi ng re qu ire d. 1, 4, 7, 10 ,1 2 4. 2 St or ag e co nd iti on s Fo r l ab or at or y- ba se d te st s, co ld st or ag e at 8 °C (i .e . c om m on re fr ig er at io n) to - n eg at iv e 70 °C is a cc ep ta bl e fo r a ny la bo ra to ry -b as ed te st in g co m po ne nt s/ co ns um ab le s. Fo r p oi nt -o f- ca re /- de ci sio n te st s, am bi en t s to ra ge c on di tio ns , 8 –4 0 °C ; no c ol d st or ag e re qu ire d. 1, 4, 7, 12 4. 3 Se rv ic e an d su pp or t Fo r l ab or at or y- ba se d te st s, su pp or t m us t be a va ila bl e fr om th e m an uf ac tu re r f or an y la bo ra to ry -b as ed e qu ip m en t a nd /o r pr oc ed ur es . Fo r p oi nt -o f- ca re /- de ci sio n te st s, no ne re qu ire d. 1, 2, 7, 12 4. 4 W as te d isp os al D oe s n ot in cl ud e m at er ia l t ha t c an no t be d isp os ed o f i n no rm al la bo ra to ry bi oh az ar d w as te st re am s. · C an b e di sp os ed o f i n re gu la r w as te (u nr eg ul at ed w as te ) a nd d oe s n ot in cl ud e m at er ia l t ha t c an no t b e di sp os ed o f i n no rm al la bo ra to ry bi oh az ar d w as te st re am s. · D ai ly th ro ug hp ut n ee ds a re c on sid er ed in th e pa ck ag in g so a s t o m in im iz e th e ne ed to d isp os e of e xt ra ne ou s p ro du ct w as te a nd /o r d isp os al o f u nu se d te st s (a lso re fe r t o Re qu ire m en t 5 .1 ). O bj ,2 ,3 ,5 ,6 ,7 ,8 ,9 4. 5 La be lli ng a nd in st ru ct io ns fo r u se (I FU ) A s p er W H O D TA G -d efi ne d re qu ire m en ts . · C om pl ia nc e re qu ire d pe r r el ev an t C E M ar k/ IV D R re qu ire m en ts (o r o th er SR A , e .g . 2 1 C FR 8 20 ) a nd W H O pr eq ua lifi ca tio n gu id an ce (s ee W H O TG S- 5: D es ig ni ng in str uc tio ns fo r u se fo r i n vi tr o di ag no sti c m ed ic al d ev ic es ) · Pr od uc t i ns er t s ha ll be a va ila bl e in re le va nt lo ca l l an gu ag e( s) a nd sh al l in cl ud e IF U s f or th e te st . · M us t p ro vi de a cc ur at e SD S in fo rm at io n on c om po ne nt s t ha t a re po te nt ia lly to xi c. W H O p re qu al ifi ca tio n la be l/I FU g ui da nc e sh ou ld b e ap pl ie d, re ga rd le ss o f w he th er te st is W H O -p re qu al ifi ed o r n ot . 11 O bj /N ee d 5. P ro du ct c os t a nd ch an ne ls M in im um Id ea l A nn ot at io n 4, 12 5. 1 Ta rg et p ri ci ng pe r s am pl e te st ed C os t e ffe ct iv e < U S$ 2 · A ct ua l p ri ce d et ai ls w ill d ep en d on o th er fa ct or s s ep ar at e fr om th e te st it se lf, w hi ch in cl ud e sh ip pi ng , s to ra ge , q ua nt iti es pu rc ha se d an d ot he r f ac to rs c om m on ly e nc ou nt er ed in n at io na l pr oc ur em en t f or n eg le ct ed tr op ic al d is ea se p ro gr am m es . · Lo w -v ol um e te st u sa ge in c er ta in si tu at io ns c re at es th e ne ed fo r p ac ka gi ng th at a llo w s o ne -a t- a- tim e us e of te st s s o as to no t c re at e sig ni fic an t p ri ce p re ss ur e fr om w as tin g of u nu se d te st s ( e. g. te st s a re p ac ka ge d fo r i nd iv id ua l u se a s o pp os ed to a la rg er n um be r p ac ka ge d to ge th er th at m us t b e us ed sh or tly a fte r op en in g [a lso re fe r t o Re qu ire m en t 4 .4 ]) . Fo r t es t c os ts u nd er th e ca te go ry “M in im al ”, th e m an uf ac tu re r is en co ur ag ed to p re se nt a c os t e ffe ct iv en es s r at io na le if th e co st pe r t es t e xc ee ds U S$ 2 (I de al ). 1, 4, 7, 10 ,1 2 5. 2 C ap ita l c os t < U S$ 1 0 00 0. 00 N on e re qu ire d. 1, 10 5. 3 Pr od uc t l ea d tim es < 12 w ee ks < 12 w ee ks “L ea d tim e” in cl ud es fu lfi lm en t a nd d el iv er y of o rd er ed te st s t o pr oc ur er . N O TE : M ay b e ad ju st ed to lo ng er le ad ti m es p ro vi de d sh el f- lif e is of su ffi ci en t d ur at io n (e .g . 2 y ea rs ). 1 5. 4 Ta rg et la un ch co un tr ie s W H O p ri or iti ze d co un tr ie s W H O p ri or iti ze d co un tr ie s O bj ,3 ,5 ,6 ,9 5. 5 Pr od uc t re gi st ra tio n (i. e. su bs ta nt ia tio n to re gu la to ry b od y of pr od uc t c la im s) C on fo rm to D TA G re qu ire m en ts . · C E M ar k/ IV D R (o r o th er S RA ) a s re le va nt · A ny re gi st ra tio n re qu ire d fo r e xp or t fr om c ou nt ry o f o ri gi n (e .g . K M FD S fr om th e Re pu bl ic o f K or ea ). · W H O p re qu al ifi ca tio n, if re qu ire d/ ap pl ic ab le · D TA G re qu ire m en ts c on fo rm · C ou nt ry -le ve l r eg ist ra tio n, if re qu ire d/ ap pl ic ab le fo r t ar ge te d co un tr ie s. D TA G : W H O D ia gn os tic T ec hn ic al A dv is or y G ro up fo r N eg le ct ed T ro pi ca l D is ea se s; EL IS A : e nz ym e- lin ke d im m un os or be nt a ss ay ; I FU : i ns tr uc tio ns fo r u se ; I V D R: In V itr o D ia gn os tic s R eg ul at io n; K M FD S: K or ea M in ist ry o f F oo d an d D ru g Sa fe ty ; PC R: p ol ym er as e ch ai n re ac tio n; R D T: ra pi d di ag no st ic te st ; S D S: sa fe ty d at a sh ee ts ; S RA : s tr in ge nt re gu la to ry a ut ho rit y; T PP : t ar ge t p ro du ct p ro fil e. 12 A nn ex 2 . O bj ec tiv es an d us e c as e O bj /N ee d O bj ec tiv e 1 2 3 4 5 6 7 8 9 10 11 12 To detect D. medinensis infections for determination of transmission interruption in animals. Testing location: Need to ideally be able to perform the test as point-of-care/-contact in potentially harsh environment (e.g. high humidity, high temperature, dirty), but a simple laboratory test is acceptable. Sampling: Need to use samples that are collected with minimal invasiveness (e.g. small volumes of capillary blood. Venous blood can also be considered). Test target: Need to detect D. medinensis infections in targeted animals (such as dogs, cats, and baboons), and particularly prepatent infections. Equipment: Need to require no complex equipment, instrumentation or water sources. Target population: Need to test all targeted animals in affected geographies. Ages tested: Need to be able to test all ages of animals. Test simplicity: Need to be able to conduct test with a minimum of training and skills (e.g. by community health workers). Performance: Need test sensitivity and specificity that meets the use case objective for transmission interruption in the animal populations tested. Readout: Need to provide a clear, qualitative indication of D. medinensis infection being confirmed or excluded. Storage/stability: Need to have no requirement for cold-chain shipping, storage or operation in intended geographies of use. However, laboratory-based methods may require some cold chain shipping and storage. Time to result: Need to generate test results in a rapid manner that is consistent with a point-of-care/ point-of-decision use case, though laboratory-based tests may take longer. Test price: Need to have a test price that is affordable to all dracunculiasise eradication programmes using the test for its intended purpose. 1. 1 In te nd ed u se × × × × 1. 2 Ta rg et ed p op ul at io n × × × 1. 3 Lo w es t i nf ra st ru ct ur e le ve l × × × × × 1. 4 Lo w es t l ev el u se r × × × × × 1. 5 Tr ai ni ng re qu ire m en ts × × × × × 2. 1 Po rt ab ili ty × × × × × 2. 2 In st ru m en t/p ow er re qu ire m en t × × × × × 2. 3 W at er re qu ire m en t × × × × 2. 4 M ai nt en an ce a nd c al ib ra tio n × × × × 2. 5 Sa m pl e ty pe /c ol le ct io n × × × × × × 2. 6 Sa m pl e pr ep ar at io n/ tr an sf er d ev ic e × × × × × 2. 7 Sa m pl e vo lu m e × × × × × 2. 8 Ta rg et a na ly te × × × × × 2. 9 Ty pe o f a na ly sis × × × × × × × 2. 10 D et ec tio n × × × × × 2. 11 Q ua lit y co nt ro l × × × × × × × 2. 12 S up pl ie s n ee de d × × × × 13 2. 13 S af et y × × × × O bj /N ee d O bj ec tiv e 1 2 3 4 5 6 7 8 9 10 11 12 To detect D. medinensis infections for determination of transmission interruption in animals. Testing location: Need to ideally be able to perform the test as point-of-care/-contact in potentially harsh environment (e.g. high humidity, high temperature, dirty), but a simple laboratory test is acceptable. Sampling: Need to use samples that are collected with minimal invasiveness (e.g. small volumes of capillary blood. Venous blood can also be considered). Test target: Need to detect D. medinensis infections in targeted animals (such as dogs, cats, and baboons), and particularly prepatent infections. Equipment: Need to require no complex equipment, instrumentation or water sources. Target population: Need to test all targeted animals in affected geographies. Ages tested: Need to be able to test all ages of animals. Test simplicity: Need to be able to conduct test with a minimum of training and skills (e.g. by community health workers). Performance: Need test sensitivity and specificity that meets the use case objective for transmission interruption in the animal populations tested. Readout: Need to provide a clear, qualitative indication of D. medinensis infection being confirmed or excluded. Storage/stability: Need to have no requirement for cold-chain shipping, storage or operation in intended geographies of use. However, laboratory-based methods may require some cold chain shipping and storage. Time to result: Need to generate test results in a rapid manner that is consistent with a point-of-care/ point-of-decision use case, though laboratory-based tests may take longer. Test price: Need to have a test price that is affordable to all dracunculiasis eradication programmes using the test for its intended purpose. 3. 1 Sp ec ie s d iff er en tia tio n/ de te ct io n × × × × 3. 2 D ia gn os tic /c lin ic al se ns iti vi ty × × × × × 3. 3 D ia gn os tic /c lin ic al sp ec ifi ci ty × × × × × 3. 4 Ti m e to re su lts × × × 3. 5 Re su lt st ab ili ty × × × × 3. 6 Th ro ug hp ut × × × 3. 7 Ta rg et sh el f- lif e/ st ab ili ty × × × × 3. 8 Ea se o f u se × × × × × 3. 9 Ea se o f r es ul ts in te rp re ta tio n × × × × × × 3. 10 O pe ra tin g te m pe ra tu re × × × × × × 4. 1 Sh ip pi ng c on di tio ns × × × 4. 2 St or ag e co nd iti on s × × × × × 4. 3 Se rv ic e an d su pp or t × × × × 4. 4 W as te d isp os al × × × × 4. 5 La be lli ng × × × × × × × × 5. 1 Ta rg et p ri ci ng p er te st × × 5. 2 C ap ita l c os t × × × × × 5. 3 Pr od uc t l ea d tim es × × 5. 4 Ta rg et la un ch c ou nt ri es × 5. 5 Pr od uc t r eg ist ra tio n × × × × ×

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