Malaria rapid diagnostic test performance : summary results of WHO product testing of malaria RDTs: Round 1-5 (2008-2013)
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Malaria rapid diagnostic test performance : summary results of WHO product testing of malaria RDTs: Round 1-5 (2008-2013)

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    WHO estimates that half the world’s population is at risk of malaria. In 2012, there were an estimated 207 million cases (with an uncertainty range of 135 million to 287 million) and an estimated 627 000 deaths (with an uncertainty range of 473 000 to 789 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring.

    WHO recommends that malaria case management be based on parasite diagnosis in all cases. The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained. The number of RDTs available and the scale of their use have increased rapidly over the past few years; however, limitations of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs. The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and nongovernmental organizations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests1 and are driving overall improvements in the quality of manufacturing.

    This summary presents an overview of the results of rounds 1–5 of malaria RDT product testing and key concepts for understanding and using the results. It is published in conjunction with the release of the full report on round 5. The results of all rounds of testing should be considered as a single data set. The separate, full reports of each round should be consulted for further details of methods, product performance and interpretation of the results.

    ISBN 978 92 4 150763 9

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