title: Evaluation of the Upgraded Version 2.0 of the Roche COBAS®AmpliPrep/COBAS®TaqMan HIV-1 Qualitative Assay in Central African Children.
abstract: BACKGROUND
  Several commercially available molecular techniques were developed based on subtype B of HIV-1, which represents only 10% of HIV strains worldwide. Indeed, in sub-Saharan Africa, non-B subtypes of HIV-1 are predominant. The aim of this study was to evaluate the performances of the COBAS®AmpliPrep/COBAS®(CAP/CTM) HIV-1 Qualitative assays to detect the broad range of HIV-1 variants circulating in Central Africa and compare to the outgoing CAP/CTM HIV-1 Quantitative test v2.0 (Roche Molecular Systems), chosen as reference gold standard molecular assay.
  
  
  METHODS
  The CAP/CTM HIV-1 Qualitative tests versions 1.0 and 2.0 (Roche Molecular Systems, Inc., Branchburg, NJ, USA) were evaluated compared to CAP/CTM TaqMan HIV-1 Quantitative test v2.0 (Roche Molecular Systems) on 239 dried plasma spot (DPS) from 133 HIV-1-infected (with detectable plasma HIV RNA load) and 106 uninfected children, followed-up at Complexe Pédiatrique, Bangui, Central African Republic.
  
  
  RESULTS
  The version 1.0 showed low sensitivity (93.2%), with 9 (6.8%) false negative results, demonstrating under-detection of non-B HIV-1 subtypes. In contrast, the upgraded version 2.0 showed 100%-sensitivity, 100%-specificity and perfect agreement (κ coefficient, 1.0).
  
  
  CONCLUSIONS
  Our evaluation in the Central African Republic demonstrates the clinical implications of the accuracy and reliability of the CAP/CTM HIV-1 Qualitative assay for early diagnosis of HIV-1 in Central African children.
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: C D
authors.initials: CD
authors.lastname: Mossoro-Kpinde
authors.affiliation: Department of Biological Sciences and BioMed Research Center, Université du Québec ā Montréal (UQAM), Montreal, Canada.
authors.forename: M A
authors.initials: MA
authors.lastname: Jenabian
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic; Complexe Pédiatrique, Bangui, Central African Republic.
authors.forename: J C
authors.initials: JC
authors.lastname: Gody
authors.affiliation: Laboratoire de virologie, hôpital Européen Georges Pompidou, and Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Robin
authors.affiliation: Laboratoire de virologie, hôpital Européen Georges Pompidou, and Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Talla
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.
authors.forename: Jdd
authors.initials: J
authors.lastname: Longo
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.
authors.forename: G
authors.initials: G
authors.lastname: Grésenguet
authors.affiliation: Laboratoire de virologie, hôpital Européen Georges Pompidou, and Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Belec
keywords: Central Africa; Dried plasma spot; Early infant diagnosis; HIV-1; Roche Molecular Systems; Subtype