Evaluation of the Upgraded Version 2.0 of the Roche COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Qualitative Assay in Central African Children



CD Mossoro-Kpinde*, 1, 2, MA Jenabian3, JC Gody2, 4, L Robin5, P Talla5, JDD Longo2, G Grésenguet2, L Belec5
1 Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic
2 Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic
3 Department of Biological Sciences and BioMed Research Center, Université du Québec ā Montréal (UQAM), Montreal, Canada
4 Complexe Pédiatrique, Bangui, Central African Republic
5 Laboratoire de virologie, hôpital Européen Georges Pompidou, and Université Paris Descartes, Paris Sorbonne Cité, Paris, France


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© Mossoro-Kpinde et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/legalcode), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic; Tel: +23675053616, E-mail: Mossoro-Kpinde@yahoo.fr


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).

Conclusion:

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.

Keywords: Central Africa, Early infant diagnosis, Dried plasma spot, HIV-1, Roche Molecular Systems, Subtype.