Journal
TROPICAL MEDICINE & INTERNATIONAL HEALTH
Volume 27, Issue 12, Pages 1059-1064Publisher
WILEY
DOI: 10.1111/tmi.13828
Keywords
actinomycetoma; eumycetoma; mycetoma; point-of-care test; target product profile; WHO
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This study discusses the development of two TPPs for mycetoma, one for diagnosing the causative agent and another for determining treatment cessation. Challenges included the multitude of agents causing mycetoma and the lack of specific biomarkers for most of them.
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.
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