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Evaluating diagnostics: the malaria guide

This collection of articles forms an operational guide on how to conduct evaluations of diagnostic tests for malaria. It was published as a special supplement in Nature Reviews Microbiology. The collection includes an introduction, two review articles and a relevant set of guidelines.

The first review, A guide for diagnostic evaluations, provides background information, discussing why good quality diagnostic tests for malaria are needed, how they are evaluated and how regulatory standards can control the introduction and use of diagnostic tests. The second, Ensuring quality and access for malaria diagnosis: how can it be achieved?, focuses on the availability and use of diagnostic tests that perform reliably and accurately under field conditions and emphasises the need for community-based health management.

The guidelines, Evaluation of rapid diagnostic tests: malaria, outline the principles for evaluating malaria rapid diagnostic tests (RDTs). It stresses the need for field tests and describes the issues that can affect study design, RDT performance, standards and quality assurance and the effects of storage and cultured parasites in lab-based trials.