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 resulting toolkit is a practical guide intended to assist users to become advocates for palliative care in a practical and effective
way. It is not necessarily a resource to read from cover to cover; rather, it can also be used selectively to each reader’s needs to engage audiences and... ensure that there is a real understanding of the need for palliative care. It should also be read in conjunction with the supplementary resources listed at the end of each of the toolkit’s sections.
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The primary audience for this guideline includes policy-makers or service providers who are responsible for developing national and local health-care protocols and policies related to care during pregnancy, childbirth and the postnatal period, and those directly providing care to women during pregna...ncy, including obstetricians, midwives, endocrinologists, nurses, general practitioners, dietitians and diabetes educators, and managers of maternal and child health programmes, in all settings.
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