02107nas a2200349   4500000000100000008004100001260001200042653002800054653002400082100001400106700001400120700001100134700001700145700001200162700001600174700001500190700001200205700001100217700001200228700001300240700001100253700001600264700001200280700001300292700001200305245005000317856008000367300001200447490000800459520127600467022001401743       2024                            d  c04/202410aTarget product profiles10aleprosy diagnostics1 aKukkaro P1 aVedithi S1 aBlok D1 avan Brakel W1 aGeluk A1 aSrikantam A1 aScollard D1 aAdams L1 aDuck M1 aAnand S1 aTucker A1 aCruz I1 aPemmaraju V1 aDagne D1 aAsiedu K1 aHanna C00aTarget product profiles: leprosy diagnostics.  uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10976862/pdf/BLT.23.290881.pdf  a288-2950 v1023 a<p>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.</p>
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