TY - JOUR KW - Target product profiles KW - leprosy diagnostics AU - Kukkaro P AU - Vedithi S AU - Blok D AU - van Brakel W AU - Geluk A AU - Srikantam A AU - Scollard D AU - Adams L AU - Duck M AU - Anand S AU - Tucker A AU - Cruz I AU - Pemmaraju V AU - Dagne D AU - Asiedu K AU - Hanna C AB -

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 or 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 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.

BT - Bulletin of the World Health Organization C1 -

https://www.ncbi.nlm.nih.gov/pubmed/38562197

DA - 04/2024 DO - 10.2471/BLT.23.290881 IS - 4 J2 - Bull World Health Organ LA - eng N2 -

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 or 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 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.

PY - 2024 SP - 288 EP - 295 T2 - Bulletin of the World Health Organization TI - Target product profiles: leprosy diagnostics. UR - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10976862/pdf/BLT.23.290881.pdf VL - 102 SN - 1564-0604 ER -