Target product profile to detect Dracunculus medinensis presence in environmental samples

Target product profile to detect Dracunculus medinensis presence in environmental samples Target product profile to detect Dracunculus medinensis presence in environmental samples Target product profile to detect Dracunculus medinensis presence in environmental samples ISBN 978-92-4-009078-1 (electronic version) ISBN 978-92-4-009079-8 (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 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 Dracunculus medinensis presence in environmental samples 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 (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 field-validated tests to detect the presence of D. medinensis-specific analytes in the environment. 2. Available diagnostic tools Although the scale of the surveillance infrastructure in countries endemic for Guinea-worm disease is impressive, initiating active surveillance and implementing disease-preventive interventions in any given area is triggered only when a host with an emergent worm is detected in that area or a nearby area. Unlike polio eradication, where an environmental diagnostic tool exists, there is no such tool for dracunculiasis eradication. Diagnostic tools that can detect evidence of analytes specific to D. medinensis in environmental samples can be used to identify geographies that are at risk for transmission of D. medinensis. Results from such environmental tools can complement surveillance data generated via active, community-based case and infection searches for subcutaneous and emergent Guinea worms and proactive or passive reporting of Guinea-worm disease. As such, environmental surveillance tools could augment current surveillance activities and enhance surveillance in a manner unprecedented for the global dracunculiasis eradication campaign. 3. Need for novel target product profiles Viable environmental assays that can detect evidence of analytes (nucleic acid or other antigens) specific to D. medinensis in various environmental samples from water, aquatic animals, and perhaps aquatic animal waste, could be used to guide the targeting and implementation of disease-preventive interventions in endemic areas. For example, such tools could further inform which surface water sources should be treated with larvicide. Environmental surveillance tools could also generate additional data to inform decision-making about when and where to contract or expand active, community-based surveillance and implement other programmatic interventions. Environmental surveillance tools would be useful for generating additional surveillance data in areas with known or suspected wildlife transmission. Diagnostic tools capable of detecting D. medinensis-specific analytes in environmental samples would also generate data on the absence of Guinea worm in the environment, which could help certify countries as free of dracunculiasis transmission, ultimately facilitate the certification of dracunculiasis eradication, and support post-certification efforts. 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 received, incorporated in the document and discussed with subgroup members, and a version V1.0 was produced. The conclusions and decisions of the subgroup were based on available evidence and 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 D ra cu nc ul us m ed in en sis p re se nc e i n en vi ro nm en ta l s am pl es 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 . m ed in en sis p re se nc e in a ny la rv al st ag e an d w hi le re sid in g ou ts id e of a m am m al ia n ho st in e nv iro nm en ta l1 sa m pl es . A n in v itr o po in t- of -in te rv en tio n/ - de ci sio n 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 p re se nc e in a ny la rv al st ag e an d w hi le re sid in g ou ts id e of a m am m al ia n ho st in e nv iro nm en ta l1 sa m pl es . 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- in te rv en tio n/ -d ec isi on 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 an d fie ld -b as ed c ol le ct io n of sp ec im en s c an b e co nd uc te d fo r tr an sp or t t o 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 -in te rv en tio n/ -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; h en ce , t hi s i s a h ig h- ri sk re qu ire m en t. If an ot he r t es t o th er th an a p oi nt -o f- in te rv en tio n 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 a w ai tin g a po in t o f i nt er ve nt io n/ -d ec isi on te st . 1 In th e co nt ex t o f t hi s T PP , t he te rm “e nv iro nm en ta l s am pl e” is d efi ne d as a sa m pl e po te nt ia lly c on ta in in g D . m ed in en sis b io lo gi ca l m at er ia l ( e. g. la rv ae , c op ep od s co nt ai ni ng la rv ae , a qu at ic a ni m al e nt ra ils a ss oc ia te d w ith D . m ed in en sis la rv ae ). A s o ut lin ed u nd er 2 .5 , s am pl e ty pe s w ou ld m os t c om m on ly b e w at er sa m pl es po te nt ia lly c on ta in in g D . m ed in en sis la rv ae (f re e or in sid e co pe po ds ), bu t a lso an y sa m pl e as so ci at ed w ith a qu at ic a ni m al s w hi ch h av e po te nt ia lly in ge st ed D . m ed in en sis la rv ae /c op ep od s w ith la rv ae . O bj ,3 ,5 ,6 1. 2 Ta rg et ed p op u- la tio n C op ep od s f ro m a qu at ic e nv iro nm en ts C op ep od s f ro m a qu at ic e nv iro nm en ts an d al l a ge s o f a qu at ic a ni m al s ( su ch as a nu ra ns o r fi sh ) t ha t i ng es t t he se co pe po ds . S pe ci m en ty pe to b e te st ed : gu t c on te nt s o r m us cl e tis su e. 1, 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- in te rv en tio n/ -d ec isi on te st , t es ts c an b e pe rf or m ed u nd er “z e- ro -in fr as tr uc tu re ” c on di tio ns in cl ud in g bu t n ot li m ite d to su rf ac e w at er so ur ce s an d aq ua tic a ni m al e nt ra il/ m us cl e tis su e co lle ct io n lo ca tio ns u nd er 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, 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 a p oi nt -o f- in te rv en tio n/ -d ec isi on te st , t he te st w ill b e pe rf or m ed b y he al th pe rs on ne l, co m m un ity h ea lth w or ke rs , an d co m m un ity v ol un te er s. 51, 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- in te rv en tio n/ -d ec isi on te st , o ne d ay o r l es s f or h ea lth p er so n- ne l, co m m un ity h ea lth w or ke rs , a nd co m m un ity v ol un te er s; te st in 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 a va ila 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- in te rv en tio n/ -d ec isi on 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 fie ld -b as ed c ol le 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 -in - te rv en tio n/ -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; h en ce , t hi s i s a h ig h- ri sk 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 bj /N ee d 2. D es ig n M in im um Id ea l A nn ot at io n 1, 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- in te rv en tio n/ -d ec isi on te st , h ig hl y po rt ab le w ith n o sp ec ia liz ed tr an sp or t n ee ds . Fo r “ Id ea l”, “P or ta bi lit y” im 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 ca n 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 in te rv en tio n. In a dd iti on , 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 a ll to ge th er in o ne co nv en ie nt lo ca tio n. W he re th er e is no p oi nt o f i nt er ve nt io n 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 o f i nt er ve nt io n an d la bo ra to ry -b as ed te st s i s a lso a cc ep ta bl e as lo ng a s i t b rin gs a dd ed va lu e 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- in te rv en tio n/ -d ec isi on te st , s el f- co nt ai ne d ki t o pe ra te s in de pe nd en t o f a ny 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- in te rv en tio n/ -d ec isi on te st , s el f- co nt ai ne d ki t o pe ra te s in de pe nd en t o f a ny 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- in te rv en tio n/ -d ec isi on te st , n o m ai nt en an ce re qu ire d (i. e. di sp os ab le ) a nd n o ca lib ra tio n re qu ire d. 61, 2, 6, 7 2. 5 Sa m pl e ty pe / co lle ct io n W at er c ol le ct io ns fr om so ur ce s su sp ec te d to c on ta in c op ep od s t ha t h av e in ge st ed D . m ed in en sis la rv ae . W at er c ol le ct io ns fr om so ur ce s su sp ec te d to c on ta in c op ep od s t ha t ha ve in ge st ed D . m ed in en sis la rv ae , a nd sa m pl es 2 t ha t a re su sp ec te d to c on ta in aq ua tic a ni m al e nt ra ils . S am pl e ty pe an d co nfi gu ra tio n co lle ct ed a lso a llo w s fo r s ub se qu en t n uc le ic a ci d se qu en ce an al ys is (f ro m a le fto ve r m at er ia l p as t ap pl ic at io n to th e sp ec ifi c te st fo r D . m ed in en sis ). 2 Sa m pl es a ss oc ia te d w ith a qu at ic a ni m al e nt ra ils c an , f or e xa m pl e, b e an im al w as te sa m pl es , a qu ae s w as he s t he re of , o r h om og en iz ed w as te sp ec im en s. 2 2. 6 Sa m pl e pr ep ar at io n/ tr an sf er d ev ic e C om pl ex ity o f s am pl e pr ep ar at io n sh al l b e co m pa tib le w ith se ct io ns 1 .3 ., 1. 4. a nd 3 .4 re la tin g to o ve ra ll te st co m pl ex ity , i nf ra st ru ct ur e le ve l r eq ui re d an d ac ce pt ab le ti m e fr om sa m pl e co lle ct io n to re su lts . · C om pl ex ity o f s am pl e pr ep ar at io n sh al l b e co m pa tib le w ith se ct io ns 1. 3. , 1 .4 . a nd 3 .4 re la tin g to o ve ra ll te st c om pl ex ity , i nf ra st ru ct ur e le ve l re qu ire d an d ac ce pt ab le ti m e fr om sa m pl e co lle ct io n to re su lts . · 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, et c. ). 1, 7 2. 7 Sa m pl e vo lu m e (p ro ce ss ed sa m pl e) N ot sp ec ifi ed < 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 pr im ar y 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. O ri gi na l s am pl e vo lu m e w ou ld b e de sc ri be d in th e te st re su lt. O 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 t he p re se nc e of D . m ed in en sis in sa m pl ed c op ep od s. Bi om ar ke r( s) sp ec ifi c fo r t he p re se nc e of D . m ed in en sis in sa m pl ed c op ep od s an d/ or o th er in fo rm at iv e bi om ar ke rs as so ci at ed w ith D . m ed in en sis in en vi ro nm en ta l s am pl es 1 a nd a qu at ic an im al e nt ra ils . 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 nt ita tiv e 71, 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 or qu an tit at iv e m ea su re . Fo r p oi nt -o f- in te rv en tio n/ -d ec isi on 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 f or n ak ed e ye , o r a c le ar ly re ad ab le in st ru m en t b as ed te st ou tp ut th at p ro vi de s a n un am bi gu ou s qu al ita tiv e or q ua nt ita tiv 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- in te rv en tio n/ -d ec isi on 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. co nt ro l l in e on a n RD 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 a nd co nt ro l f or sa m pl e ad eq ua cy . 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 , e tc .)? If co lle ct io n is ba se d on c op ep od s c on ta in in g L3 la rv ae , a n ad eq ua cy c on tr ol c ou ld c on sis t i n us e of a c op ep od h ou se ke ep in g ge ne d et ec te d vi a PC R. A si m ila r a pp ro ac h co ul d be a pp lie d to te st in g of a qu at ic a ni m al e nt ra ils . 1, 2, 4, 7, 12 2. 12 S up pl ie s ne ed ed Fo r l ab or at or y- ba se d te st s, th e te st ki t c on ta in s a ll re ag en ts n ee de d th at c an b e ob ta in ed 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 i m po rt re st ri ct io ns ). N ec es sa ry eq ui pm en t n ot p ro vi de d in a re ag en t k it m ay in cl ud e sp ec ifi c in st ru m en ts a nd co m m on ly u se d la bo ra to ry e qu ip m en t. Fo r p oi nt -o f- in te rv en tio n/ -d ec isi on te st s: Ex ce pt fo r a o ne -t im e pu rc ha se in st ru m en t t ha t m ay b e re qu ire d fo r th e te st , a ll re ag en ts a nd o th er su pp lie s in cl ud ed 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 i m po rt re st ri ct io ns ). 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 . 8O 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 iff er en tia te d fr om o th er po te nt ia lly c ro ss -r ea ct in g pa th og en s o r D ra cu nc ul us sp ec ie s. D . m ed in en sis , d iff er en tia te d fr om o th er po te nt ia lly c ro ss -r ea ct in g pa th og en s o r D ra cu nc ul us sp ec ie s. O bj ,3 ,5 ,8 ,9 3. 2 D ia gn os tic /c lin - ic al se ns iti vi ty 70 % > 80 % It w as n ot p os sib le to c on du ct a b in iti o pe rf or m an ce m od el lin g fo r t he d et er m in at io n of se ns iti vi ty a nd sp ec ifi ci ty re qu ire m en ts sin ce th er e ar e no m od el lin g pr ec ed en ts a va ila bl e du e to a la ck o f su ita bl y de sig ne d te st in g to ol s b ei ng a va ila bl e (i. e. th os e te st in g to ol s w ho se d es ig n w ou ld b e in fo rm ed b y th is TP P) . A s a m ea ns to b re ak th ro ug h th is st al em at e, se ns iti vi ty a nd sp ec ifi ci ty v al ue s w er e se le ct ed th at w ill in p ri nc ip le e na bl e re lia bl e de te ct io n in ci rc um st an ce s w he re e lim in at io n is un de rg oi ng c on fir m at io n. Fo r e xa m pl e, w he n co nfi rm in g el im in at io n th er e w ill a lre ad y be a su bs ta nt ia l a m ou nt o f n on -e nv iro nm en ta l d at a su gg es tin g th at en vi ro nm en ta l d et ec tio n of D . m ed in en sis is n ot g oi ng to b e lik el y. Si nc e w e ar e no t s tr ic tly d ep en di ng o n th is te st to m ak e th at d e- te rm in at io n bu t r at he r o n ot he r i nd ic at iv e da ta so ur ce s, se tti ng a m od er at e se ns iti vi ty re qu ire m en t ( m in im um = 7 0% , i de al > 8 0% ) en su re s t ha t o nl y sig ni fic an t/” st an d- ou t” e nv iro nm en ta l s ou rc es of D . m ed in en sis w ill b e de te ct ed . In a dd iti on , b y se tti ng a m or e st ri ng en t s pe ci fic ity re qu ire m en t ( m in im um = 9 0% , i de al > 9 5% ), th e te st w ill e ng en de r a re la tiv el y lo w ra te o f “ fa lse a la rm s” th at w ou ld c al l i nt o qu es tio n or ch al le ng e el im in at io n. (N O TE : I t i s i m po rt an t t o em ph as iz e th at th es e re co m m en de d se ns iti vi ty a nd sp ec ifi ci ty re qu ire m en ts a re m ea nt to p ro vi de a st ar tin g po in t s o th at e nv iro nm en ta l d at a fo r D . m ed in en sis c an be c ol le ct ed a nd th us e na bl e pe rf or m an ce m od el lin g to o cc ur in th e fu tu re , w hi ch in tu rn w ill p ro vi de m or e re fin ed e st im at es fo r se ns iti vi ty a nd sp ec ifi ci ty re qu ire m en ts in su bs eq ue nt v er sio ns of th is TP P. ). 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 of e vi de nc e an d lin es o f e vi de nc e. Th e ce rt ifi ca tio n pr oc es s w ill co ns id 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 ov er al l. O bj ,3 ,5 ,8 ,9 3. 3 D ia gn os tic /c lin - ic al sp ec ifi ci ty 90 % > 95 % A na ly tic al se ns i- tiv ity In th e ab se nc e of a re lia bl e go ld st an da rd fo r d et ec tio n of D . m ed i- ne ns is in fe ct io us m at er ia ls (c op ep od s i ng es te d la rv ae ) i n en vi ro n- m en ta l s am pl es , t he a ch ie ve d an al yt ic al se ns iti vi ty c an b ec om e a pr el im in ar y pe rf or m an ce p ar am et er . D ep en di ng o n th e na tu re o f th e te st m et ho d ap pl ie d, th e an al yt ic al se ns iti vi ty c an b e m ea su re d in a n “a na ly te /v ol um e” o f w at er so ur ce sa m pl ed . A th re sh ol d co ul d be d et ec tio n of fi ve c op ep od s c on ta in in g L3 la rv ae /li tr e of pr im ar y sa m pl e (p on d w at er c ol le ct ed ). 91, 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 O C te st , ≤ 1 0 m in fr om sa m pl in g to re su lt. “T im e to re su lt” is d efi ne d as th e tim e el ap se d fr om p ri m ar y sa m pl e co lle ct io n to a te st re su lt. 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- in te rv en tio n an d la bo ra to ry -b as ed te st re su lts w ou ld p ro vi de ce nt ra liz 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 st ab ili ty ” ( vi a 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- in te rv en tio n/ -d ec isi on 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) . 1, 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 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- in te rv en tio n/ -d ec isi on te st s or sp ec im en c ol le 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 u se d in th e fi eld . · Co ns um ab les 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 ”) . So m 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. 10 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 of st ep s a nd c om pl ex ity o f s am pl in g an d te st 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 . Te st co m pl ex ity a llo 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 us e in a n un pr ot ec te d an d po te nt ia lly ha rs h ex te rn al e nv iro nm en t ( e. g. hi gh te m pe ra tu re , h ig h hu m id ity [s ee Re qu ire 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 O C fie ld u se , s am pl e co lle ct io n an d te st pr oc ed ur e st ep s c an b e ad eq ua te ly de sc ri be d on a (“ qu ic k gu id e” st yl e) ch ec k- lis t/c ha rt . 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 ha rs h ex te rn al e nv iro nm en t ( e. g. hi gh te m pe ra tu re , h ig h hu m id ity [s ee Re qu ire m en t 3 .1 0] ). Sa m pl e co lle ct io n an d te st c om pl ex ity is n ot n ec es sa ri ly d es cr ib ed by n um be r o f p ro ce du ra l 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 c om 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 pa rt iti on s m ay a llo w to m in im iz 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- in te rv en tio n 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 de fin ed 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 20 –4 0 °C , 7 5% re la tiv e hu m id ity 15 –4 5 °C , 9 9% re la tiv e hu m id ity 11 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) is 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- in te rv en tio n/ -d ec isi on 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 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- in te rv en tio n/ -d ec isi on te st s, am bi en t s to ra ge c on di tio ns , 8– 40 °C ; n o co ld 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 b e av ai la bl e fr om 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- in te rv en tio n/ -d ec isi on 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. 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 s) · 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. · C om pl ia nc e w ith D TA G 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 P Q gu id an ce (s ee W H O T G 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. · C om pl ia nc e w ith D TA G re qu ire m en ts . 12 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$ 5 0 · A s t hi s t es tin g aff ec ts c om m un iti es , a h ig he r p ri ce p oi nt o f u p to U S$ 5 0 is ac ce pt ab le . Th e de ve lo pe rs a re e nc ou ra ge d to p ro vi de a ra tio na le o n th e co st –e ffe ct iv en es s o f t he ir o ffe ri ng s. · 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 ]) . 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 or c an b e pe rf or m ed on c om m on ly p re -e xi st in g sim pl e la bo ra to ry e qu ip m en t. 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 om pl ia nc e w ith D TA G re qu ire m en ts . · C om pl ia nc e w ith 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 · 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. 13 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 for determination of its presence in aquatic environments. Testing location: Need to be able/is preferable to perform the test as point-of-contact/-decision in potentially harsh environment (e.g. high humidity, high temperature, dirty), but acceptable to have a laboratory-based test. Sampling: Need to function with complex environmental water sample matrices, to detect larvae of D. medinensis within copepods. Test target: Need to detect D. medinensis in copepods and/ or aquatic animal hosts (such as anurans or fish) that ingest copepods. Specimen type could be muscles, gut contents, etc. Equipment: Need to require no complex equipment, instrumentation or water sources. Target population: Need to detect D. medinensis in aquatic bulk invertebrates and/or in aquatic animals that ingest them. Population to be targeted is environmental in nature. Samples may be from (i) concentrated environmental water samples, (ii) tissues or gut contents from fish or anurans. Ages tested: Need to be able to test environmental samples including from various aquatic organisms of all ages. Test simplicity: Need to be able to conduct test with a minimum of training and skills, but acceptable to require laboratory/clinic technician level training. Performance: Need test sensitivity and specificity that meets the use case objective for detecting presence in the aquatic environments [e.g. bulk copepods, entrails and/or tissues of aquatic animals (such as anurans or fish)]. Readout: Need to provide a clear, qualitative indication of D. medinensis presence confirmed or excluded. Storage/stability: Need to have no requirement for cold-chain shipping, storage or operation in intended geographies of use. 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/use case. 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 × × × × × 2. 13 S af et y × × × × 14 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 for determination of its presence in aquatic environments. Testing location: Need to be able/is preferable to perform the test as point-of-contact/-decision in potentially harsh environment (e.g. high humidity, high temperature, dirty), but acceptable to have a laboratory-based test. Sampling: Need to function with complex environmental water sample matrices, to detect larvae of D. medinensis within copepods. Test target: Need to detect D. medinensis in copepods and/ or aquatic animal hosts (such as anurans or fish) that ingest copepods. Specimen type could be muscles, gut contents, etc. Equipment: Need to require no complex equipment, instrumentation or water sources. Target population: Need to detect D. medinensis in aquatic bulk invertebrates and/or in aquatic animals that ingest them. Population to be targeted is environmental in nature. Samples may be from (i) concentrated environmental water samples, (ii) tissues or gut contents from fish or anurans. Ages tested: Need to be able to test environmental samples including from various aquatic organisms of all ages. Test simplicity: Need to be able to conduct test with a minimum of training and skills, but acceptable to require laboratory/clinic technician level training. Performance: Need test sensitivity and specificity that meets the use case objective for detecting presence in the aquatic environments [e.g. bulk copepods, entrails and/or tissues of aquatic animals (such as anurans or fish)]. Readout: Need to provide a clear, qualitative indication of D. medinensis presence confirmed or excluded. Storage/stability: Need to have no requirement for cold-chain shipping, storage or operation in intended geographies of use. 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/use case. 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. 4 Ti m e to re su lts × × × 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 × × × × × Neglected tropical diseases 20 Avenue Appia 1211 Geneva 27 Switzerland neglected.diseases@who.int https://www.who.int/teams/control-of-neglected-tropical-diseases