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According to the World Health Organization (WHO), the priority diagnostic needs for human African trypanosomiasis (HAT) are a test for gambiense HAT (gHAT) to identify individuals to receive widened treatment and a test for rhodesiense HAT (rHAT) usable in peripheral health facilities. The ERASE project will develop rapid diagnostic tests (RDT) compliant with the respective WHO target product profiles. For gHAT, current RDTs have inadequate specificity. ERASE will develop a 2nd generation antibody detection gHAT RDT with improved diagnostic performance, incorporating the best selected recombinant antigens. The gHAT RDT performance will be evaluated in 3 clinical trials in epidemiologically different gHAT foci in West- and Central Africa. Manufacturing of the gHAT RDT will be transferred to an African SME (TRL8/9). Diagnosis of rHAT relies on microscopy, resulting in underdetection. For rHAT, ERASE will identify target antigens and develop an antigen capture RDT using the innovative Affimer technology. After evaluation of its clinical performance on biobanked specimens and in a clinical trial, the rHAT RDT will be ready for industrialisation (TRL6). Mapping of health centres, forecasting of RDT consumption and implementation costs, and social research will pave the way for future rHAT RDT introduction. The consortium consists of commercial, non-for profit, academic and governmental partners, including an SME with experience in HAT RDT commercialisation, and will ensure successful RDT development and sustainable production and implementation. Both RDTs will support HAT elimination as targeted by the WHO neglected tropical diseases roadmap. The gHAT RDT will be applicable in a “test & treat” strategy to rapidly stop gHAT transmission. The rHAT RDT will revolutionize rHAT management, allowing faster diagnosis and safer treatment. It will strengthen rHAT surveillance, lead to faster detection of outbreaks and will facilitate elimination of rHAT as a public health problem.
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