Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
procédures : guide méthodologique
Pour l'achat de tests de diagnostic rapide du paludisme (TDR), plusieurs critères sont recommandés pour garantir la qualité et l'efficacité des tests. Ces critères se basent notamment sur la performance des tests, leur stabilité, leur facilité d'utilisation, leur coût et leur conformité aux... standards de l'Organisation Mondiale de la Santé (OMS)
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This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional considerations in the procurement of rapid tests.
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingui...sh between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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(version 1.0): procedure: methods manual