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.
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La troisième édition du RSI intègre les amendements à l’annexe 7 qui ont été adoptés par la Soixante-Septième Assemblée mondiale de la Santé, par la résolution WHA67.13 (2014). Aux termes de l’annexe 7 modifiée, la durée de la protection conférée par l’administration d’un vacc...in approuvé contre la fièvre jaune, et la validité du certificat de vaccination correspondant, s’étendent à la vie entière du sujet vacciné et ne se limitent plus à 10 ans, comme prévu auparavant.
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Adolescents and young adults aged 10-24 remain underserved in the global response against HIV. Combination prevention, treatment and care programmes use a mix of evidence-based interventions to meet the current HIV prevention needs of adolescents and young adults. However, there needs to be a focus ...on priority interventions that are evidence-based, practical, contextual and sustainable. This document highlights interventions and recommendations that have passed through the evidence-based lens of the WHO.
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