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 summarises the minimum performance requirements, includin...g 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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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 summarises the minimum performance requirements, includin...g 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.
more
Componente del Juego de herramientas para la prevención:“Cómo mejorar la salud y el desarrollo de su niño/a”
This Communications Toolkit is intended to provide practical guidance and support to staff and partners who are looking to increase their communications capacity. It has been developed as a resource for project staff who work at field-level, to help them communicate responsibly, creatively, and effe...ctively about their work
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Moving from accelerated burden reduction to malaria elimination in Zambia
Case Management; Guide for Tutors