Literature DB >> 26706730

Performance of Roche CAP/CTM HIV-1 qualitative test version 2.0 using dried blood spots for early infant diagnosis.

Sokhna Bousso Gueye1, Halimatou Diop-Ndiaye2, Mamadou Malick Diallo3, Omar Ly4, Aissatou Sow-Ndoye5, Ndèye Diabou Diagne-Gueye6, Khady Kébé-Fall7, Fatou Diop8, Aïssatou Gaye-Diallo9, Laurent Belec10, Souleymane Mboup11, Coumba Touré-Kane12.   

Abstract

In the context of early infant diagnosis (EID) decentralization in sub-Saharan Africa, dried blood spot (DBS) is now widely used for HIV proviral DNA detection in resource-limited settings. A new version of CAP/CTM (version 2) has been introduced, recently by Roche Diagnosis as a new real-time PCR assay to replace previous technologies on qualitative detection of HIV-1 DNA using whole blood and DBS samples. The objective of this study was to evaluate CAP/CTM version 2 compared to CAP/CTM version 1 and Amplicor on DBS. A total of 261 DBS were collected from children aged 4 weeks to 17 months born from HIV-seropositive mothers and tested by the three techniques. CAP/CTM version 2 showed 100% of agreement with Amplicor including 74 positive results and 187 negative results. CAP/CTM version 2 versus CAP/CTM version 1 as well as CAP/CTM version 1 versus Amplicor showed two discordant results giving a sensitivity of 98.6%, specificity of 99.5%, positive predictive value of 98.6% and negative predictive value of 99.5%. The concordance was 99.12% (95% of confidence interval) giving a Kappa coefficient of 0.97 (p<0.001). These findings confirmed the expected good performance of CAP/CTM version 2 for HIV-1 EID.
Copyright © 2015 Elsevier B.V. All rights reserved.

Entities:  

Keywords:  CAP/CTM v 2.0; DBS; Early infant diagnosis; HIV-1

Mesh:

Substances:

Year:  2015        PMID: 26706730     DOI: 10.1016/j.jviromet.2015.12.006

Source DB:  PubMed          Journal:  J Virol Methods        ISSN: 0166-0934            Impact factor:   2.014


  5 in total

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

Authors:  C D Mossoro-Kpinde; M A Jenabian; J C Gody; L Robin; P Talla; Jdd Longo; G Grésenguet; L Belec
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  5 in total

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