2026-07-21T14:14:54Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/159512025-06-19T07:29:45Zcom_20.500.12105_2052com_20.500.12105_2051col_20.500.12105_19613

00925njm 22002777a 4500 dc Fongwen, Noah author Asiedu, Kingsley B author Bakhiet, Sahar author Bonifaz, Alexandro author Cruz, Israel author Argaw, Daniel author Estrada-Chavez, Guadalupe author Fahal, Ahmed H author Litvintseva, Ana author Marks, Michael author Salinas-Carmona, Mario C author Sow, Doudou author van de Sande, Wendy W J author 2022-12 Objective: Mycetoma is a neglected tropical disease caused by more than 70 different microorganisms and identified by the WHO as one of the high-priority diseases for developing diagnostic tests. To ensure the production of diagnostic assays for use by clinical staff in endemic regions, target product profiles (TPPs) were designed. Methods: We describe the development of two TPPs: one for a diagnostic test able to identify the causative agent of mycetoma and another that would determine when treatment could be stopped. The TPPs were developed by considering product use, design, performance, product configuration and costs. Results: Version 1.0 TPPs for two uses were posted by WHO for a 1-month online public consultation on 25 October 2021, and the final TPP was posted online on 5 May 2022. Conclusion: A major difficulty encountered in developing both TPPs was the large number of agents able to cause mycetoma and the lack of specific biomarkers for most of them. Trop Med Int Health. 2022 Dec;27(12):1059-1064. 10.1111/tmi.13828 1365-3156 Tropical medicine & international health : TM & IH 36329624 http://hdl.handle.net/20.500.12105/15951 Actinomycetoma Eumycetoma Mycetoma Point-of-care test Target product profile WHO Diagnostics to support mycetoma management-Development of two target product profiles