Target Product Profile for a point-of-care diagnostic test for dermal leishmaniases

by Cruz I, Albertini A, Barbeitas M, Arana B, Picado A, Ruiz-Postigo JA, Ndung’u JM. Parasite Epidemiology and Control 2019, e00103. doi: 10.1016/j.parepi.2019.e00103

Summary: Microscopy is the reference test for diagnosis of dermal leishmaniasis, but it has low and variable sensitivity and requires well-trained personnel. The technical complexity and cost of the more sensitive molecular techniques (e.g. PCR) limits their application in routine diagnosis in endemic areas. Point-of-care (POC) tests for early diagnosis are much needed in order to benefit both patients and communities, by reducing the risk of both sequelae and Leishmania transmission. The authors describe a Target Product Profile for a POC test for dermal leishmaniases, which was defined through several rounds of discussions and by consensus with stakeholders and experts in dermal leishmaniases.

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