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ng renewed attention to surveillance and outbreak control in 2021.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar
...
ises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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