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

Sokhna Bousso Gueye; Halimatou Diop-Ndiaye; Mamadou Malick Diallo; Omar Ly; Aissatou Sow-Ndoye; Ndèye Diabou Diagne-Gueye; Khady Kébé-Fall; Fatou Diop; Aïssatou Gaye-Diallo; Laurent Belec; Souleymane Mboup; Coumba Touré-Kane

doi:10.1016/j.jviromet.2015.12.006

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

J Virol Methods. 2016 Mar:229:12-5. doi: 10.1016/j.jviromet.2015.12.006. Epub 2015 Dec 17.

Affiliations

¹ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
² Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
³ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁴ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁵ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁶ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁷ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁸ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
⁹ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
¹⁰ Laboratoire de Virologie, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital, Européen Georges Pompidou/Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France. Electronic address: [email protected].
¹¹ Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].
¹² Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: [email protected].

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

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.

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

Publication types

Comparative Study
Evaluation Study

MeSH terms

Africa South of the Sahara
Blood / virology*
DNA, Viral / analysis*
DNA, Viral / genetics
Desiccation
HIV Infections / diagnosis*
HIV-1 / genetics
HIV-1 / isolation & purification*
Humans
Infant
Molecular Diagnostic Techniques / methods*
Predictive Value of Tests
Real-Time Polymerase Chain Reaction / methods*
Sensitivity and Specificity
Specimen Handling / methods*
Viral Load / methods

Substances

DNA, Viral