Monday, December 28, 2015

Performance of Roche CAP/CTM HIV-1 Qualitative Test Version 2.0 Using Dried Blood Spots for Early Infant Diagnosis

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.

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1Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: sbgueye@yahoo.fr.
2Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: halimatoudiop@yahoo.fr.
3Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: malickdiari@yahoo.fr.
4Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: omarlyster@gmail.com.
5Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: sowaicha@yahoo.fr.
6Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: diabou.diagne@yahoo.fr.
7Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: didi_sn@yahoo.fr.
8Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: fatyraza@hotmail.fr.
9Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: ayougayediallo@gmail.com.
10Laboratoire 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: prbelecl@yahoo.fr.
11Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: virus@orange.sn.
12Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: ctourekane@yahoo.co.uk.
  


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