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- Title
Target product profiles: leprosy diagnostics.
- Authors
Kukkaro, Petra; Vedithi, Sundeep Chaitanya; Blok, David J.; van Brakel, Wim H.; Geluk, Annemieke; Srikantam, Aparna; Scollard, David; Adams, Linda B.; Duck, Mathias; Anand, Sunil; Tucker, Andie; Cruz, Israel; Pemmaraju, VRR; Dagne, Daniel Argaw; Asiedu, Kingsley; Hanna, Christopher
- Abstract
The World Health Organization (WHO) aims to reduce new leprosy cases by 70% by 2030, necessitating advancements in leprosy diagnostics. Here we discuss the development of two WHO's target product profiles for such diagnostics. These profiles define criteria for product use, design, performance, configuration and distribution, with a focus on accessibility and affordability. The first target product profile outlines requirements for tests to confirm diagnosis of leprosy in individuals with clinical signs and symptoms, to guide multidrug treatment initiation. The second target product profile outlines requirements for tests to detect Mycobacterium leprae or M. lepromatosis infection among asymptomatic contacts of leprosy patients, aiding prophylactic interventions and prevention. Statistical modelling was used to assess sensitivity and specificity requirements for these diagnostic tests. The paper highlights challenges in achieving high specificity, given the varying endemicity of M. leprae, and identifying target analytes with robust performance across leprosy phenotypes. We conclude that diagnostics with appropriate product design and performance characteristics are crucial for early detection and preventive intervention, advocating for the transition from leprosy management to prevention.
- Subjects
HANSEN'S disease diagnosis; WORLD Health Organization; HEALTH services accessibility; PRODUCT design; DISEASE management; NEW product development; RAPID diagnostic tests; COMMERCIAL product evaluation; HANSEN'S disease; EARLY diagnosis; MEDICAL care costs
- Publication
Bulletin of the World Health Organization, 2024, Vol 102, Issue 4, p288
- ISSN
0042-9686
- Publication type
Article
- DOI
10.2471/BLT.23.290881