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AIDS Research and Treatment
Volume 2016 (2016), Article ID 7954810, 12 pages
http://dx.doi.org/10.1155/2016/7954810
Research Article

Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification

1Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic
2Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic
3Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France
4Université Paris Descartes, Paris Sorbonne Cité, Paris, France
5Département des Sciences Biologiques et Centre de Recherche BioMed, Université du Québec à Montréal (UQAM), Montreal, QC, Canada
6Faculté de Médecine, Université de Bunia, Bunia, Democratic Republic of the Congo
7Centre National de Référence des Maladies Sexuellement Transmissibles et de la Thérapie Antirétrovirale, Bangui, Central African Republic
8Unité de Recherches et d’Intervention sur les Maladies Sexuellement Transmissibles et le SIDA, Département de Santé Publique, Faculté des Sciences de la Santé de Bangui, Bangui, Central African Republic
9Laboratoire de Virologie Médicale et Moléculaire, EA-4684/SFR CAP-SANTE, Reims, France

Received 6 June 2016; Accepted 3 October 2016

Academic Editor: Robert R. Redfield

Copyright © 2016 Christian Diamant Mossoro-Kpinde et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting gag and LTR, using samples from HIV-1-infected adults from Central African Republic. Results. Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4–10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. Conclusions. The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa.