A Y Dagnra1, S Dossim2, M Salou2, T Nyasenu2, K Ali-Edje2, A Ouro-Médeli2, M Doufan2, A Ehlan2, M Prince-David2. 1. Centre national de référence pour les tests VIH/IST-PNLS, CHU Sylvanus-Olympio, 08 BP, 8742 Lomé 08, Togo. Electronic address: a.dagnra@yahoo.fr. 2. Centre national de référence pour les tests VIH/IST-PNLS, CHU Sylvanus-Olympio, 08 BP, 8742 Lomé 08, Togo.
Abstract
PURPOSE: HIV rapid diagnostic tests (RDT) could be greatly contributive for a universal access to HIV diagnosis. However, according to the WHO, these tests need to be assessed before they can be used in routine. METHOD AND RESULTS: We assessed 9 RDT in routine clinical use between 2009 and 2013. The sensitivity and specificity observed for 7 tests were≥99% and≥98%, respectively: FIRST RESPONSE HIV1-2-O PMC Medical, India, GENIE Fast HIV 1-2 and GENIE™ III HIV(1/2) Bio-Rad, France, HIV TRI-DOT+Ag;J. Mitra, INDIA; SD BIOLINE HIV(1/2) 3.0 and SD BIOLINE HIV/SYPHILIS DUO Standard Diagnostic, Korea; and VIKIA HIV(1/2); BioMérieux, France. Two tests had performances inferior to WHO recommendations: INSTI HIV1/2 Biolytical Canada; sensitivity=97.8% and HEXAGON HIV HUMAN GmbH Germany; specificity=94.8%. CONCLUSION: Seven of 9 RDT had excellent performances. Nevertheless, they can be used only after training staff, and taking into account national algorithm for their safe use.
PURPOSE: HIV rapid diagnostic tests (RDT) could be greatly contributive for a universal access to HIV diagnosis. However, according to the WHO, these tests need to be assessed before they can be used in routine. METHOD AND RESULTS: We assessed 9 RDT in routine clinical use between 2009 and 2013. The sensitivity and specificity observed for 7 tests were≥99% and≥98%, respectively: FIRST RESPONSE HIV1-2-O PMC Medical, India, GENIE Fast HIV 1-2 and GENIE™ III HIV(1/2) Bio-Rad, France, HIV TRI-DOT+Ag;J. Mitra, INDIA; SD BIOLINE HIV(1/2) 3.0 and SD BIOLINE HIV/SYPHILIS DUO Standard Diagnostic, Korea; and VIKIA HIV(1/2); BioMérieux, France. Two tests had performances inferior to WHO recommendations: INSTI HIV1/2 Biolytical Canada; sensitivity=97.8% and HEXAGON HIV HUMAN GmbH Germany; specificity=94.8%. CONCLUSION: Seven of 9 RDT had excellent performances. Nevertheless, they can be used only after training staff, and taking into account national algorithm for their safe use.
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