title: Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification.
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 targetinggagandLTR, 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.
authors.affiliation: Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic; Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.
authors.forename: Christian Diamant
authors.identifier: 0000-0002-9259-1770
authors.initials: CD
authors.lastname: Mossoro-Kpinde
authors.affiliation: Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France; Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: Ralph-Sydney
authors.initials: RS
authors.lastname: Mboumba Bouassa
authors.affiliation: Département des Sciences Biologiques et Centre de Recherche BioMed, Université du Québec à Montréal (UQAM), Montreal, QC, Canada.
authors.forename: Mohammad-Ali
authors.initials: MA
authors.lastname: Jenabian
authors.affiliation: Faculté de Médecine, Université de Bunia, Bunia, Democratic Republic of the Congo.
authors.forename: Serge Tonen
authors.initials: ST
authors.lastname: Wolyec
authors.affiliation: Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Leman
authors.initials: L
authors.lastname: Robin
authors.affiliation: Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Matta
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic; Centre National de Référence des Maladies Sexuellement Transmissibles et de la Thérapie Antirétrovirale, Bangui, Central African Republic; Unité 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.
authors.forename: Jean de Dieu
authors.initials: JD
authors.lastname: Longo
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic; Unité 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.
authors.forename: Gérard
authors.initials: G
authors.lastname: Grésenguet
authors.affiliation: Laboratoire de Virologie Médicale et Moléculaire, EA-4684/SFR CAP-SANTE, Reims, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Andreoletti
authors.affiliation: Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France; Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Bélec