The World Health Organization estimates that half the world’s population are at risk of malaria, with 243 million people developing clinical malaria last year (86% in Africa), with nearly 863,000 deaths (89% in Africa, most being children). Malaria remains endemic in 108 countries, and while parasitebased diagnosis is increasing, most suspected cases of malaria are still not properly identified, resulting in over-use of anti-malarial drugs and poor disease monitoring.
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WHO recommends that malaria case management be based on parasite-based diagnosis in all cases. The use of antigendetecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, forming the backbone of expansion of access to malaria diagnosis as they provide parasite-based diagnosis in areas where good quality microscopy can not be maintained.
The number of RDTs available, and the scale of their use, has rapidly increased over the past few years. However, limitations of comparative field trials and the heterogeneous nature of malaria transmission and epidemiology has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implementation, and limits the ability to extrapolate results of field trials to different populations and time periods. To this end in 2006, the World Health Organization (WHO), Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched an evaluation programme to assess the comparative performance of commercially available malaria RDTs. This data will guide procurement decisions and help drive improvement in the quality of manufacturing.
The results of the first round of Product Testing were published in April 2009, and now form the basis of procurement criteria of WHO and UN agencies and national governments. This Summary presents an overview of the results of the first and second rounds of WHO product testing of malaria antigen-detecting RDTs completed in 2008 and 2009 respectively, and is published in conjunction with the release of the results of Round 2. The results of the two rounds of testing should be considered as a single data set, and the full reports of both Rounds 1 and 2 consulted for further detail on product performance, and on the interpretation and use of these results.