Diagnostics to support mycetoma management-Development of two target product profiles.

Fongwen, Noah; Asiedu, Kingsley B; Bakhiet, Sahar; Bonifaz, Alexandro; Cruz, Israel; Argaw, Daniel; Estrada-Chavez, Guadalupe; Fahal, Ahmed H; Litvintseva, Ana; Marks, Michael; +3 more... Salinas-Carmona, Mario C; Sow, Doudou; van de Sande, Wendy WJ; (2022) Diagnostics to support mycetoma management-Development of two target product profiles. Tropical Medicine & International Health, 27 (12). pp. 1059-1064. ISSN 1360-2276 DOI: https://doi.org/10.1111/tmi.13828

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.

Additional Information

Item Type	Article
Faculty and Department	Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
PubMed ID	36329624
Elements ID	196232
Official URL	http://dx.doi.org/10.1111/tmi.13828

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