Vérification des performances de la méthode COBAS® AmpliPrep/COBAS® TaqMan HIV-1 test, v 2.0 pour la quantification de la charge virale plasmatique du VIH-1.

Abstract

The laboratory of the National Institute of Public health makes HIV-1 plasma RNA quantification. That test is required to follow up HIV patient on ART (Antiretroviral therapy). The laboratory was accredited by the West African Accreditation System (SOAC) in 2022 for HIV real time PCR. Here we report the experience of the laboratory for verifiying performance of the COBAS® AmpliPrep/COBAS® TaqMan (CAP/CTM) HIV-1 test, v 2.0 kit for measuring viral load by real time PCR. According with the technical guides of the French Accreditation Committee (COFRAC) and the recommendations of the French Society of Clinical Biology (SFBC), different steps were followed. These are the risk assessment, the study of reliability, intermediate precision, accuracy and precision of the method, estimation of measurement uncertainty and comparison of methods. Coefficient of variation for repeatability, reproducibility and trueness were within target of 5 %. The results from the CAP/CTM were reproductible and identical to those of the COBAS 6800. The COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Test, v 2.0 method is suitable for routine laboratory use and has analytical performance for its intended utility, which mean the assessment of disease progression and monitoring of antiretroviral therapy for HIV-1 patients.