Diagnostics to support mycetoma management—Development of two target product profiles

Noah Fongwen, Kingsley B. Asiedu, Sahar Bakhiet, Alexandro Bonifaz, Israel Cruz, Daniel Argaw, Guadalupe Estrada-Chavez, Ahmed H. Fahal, Ana Litvintseva, Michael Marks, Mario C. Salinas-Carmona, Doudou Sow, Wendy W.J. van de Sande*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Pages (from-to)1059-1064
Number of pages6
JournalTropical Medicine and International Health
Volume27
Issue number12
Early online date3 Nov 2022
DOIs
Publication statusPublished - Dec 2022

Bibliographical note

Funding Information:
The authors would like to thank all experts and colleagues who provided useful comments through the public consultation via https://www.who.int/news-room/articles-detail/public-consultation-tpps-for-mycetoma-diagnostics.

Publisher Copyright:
© 2022 The Authors Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

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