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Malaria rapid diagnostic test performance; summary results of WHO malaria RDT product testing: rounds 1-3 (2008-2011)
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Description:"The RDT evaluations summarized here were performed as a collaboration between WHO, TDR, FIND, the US Centers for Disease Control and Prevention (CDC) and other partners. All companies manufacturing under ISO 13485:2003 Quality System Standard were invited to submit up to 3 tests for evaluation under the programme. In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites, while 29 products from 13 manufacturers were evaluated in Round 2. In Round 3, 50 products were evaluated from 23 manufacturers, including 23 products re-submitted from earlier rounds (Table S3). Of these 120 total products, 118 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after two months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. Of the 118 fully evaluated products, 25 have been evaluated in more than one round. Of the 95 unique products tested by the programme, 29 detect P. falciparum alone, 57 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species specific), 8 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. Where the same products4 have been re-submitted in subsequent rounds of testing, the latter results replace results published from the earlier round. Thus, the performance of many tests in the results below differ from those published in the Round 1 and Round 2 reports. The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement decisions of WHO and other UN agencies and national governments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad implementation of reliable malaria diagnosis in areas where malaria is prevalent. A fourth round of product testing began in June 2011." - p. 1
"TDR/RDT/11.1."
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