title: Performance of Roche CAP/CTM HIV-1 qualitative test version 2.0 using dried blood spots for early infant diagnosis.
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.
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: sbgueye@yahoo.fr.
authors.forename: Sokhna Bousso
authors.initials: SB
authors.lastname: Gueye
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: halimatoudiop@yahoo.fr.
authors.forename: Halimatou
authors.initials: H
authors.lastname: Diop-Ndiaye
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: malickdiari@yahoo.fr.
authors.forename: Mamadou Malick
authors.initials: MM
authors.lastname: Diallo
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: omarlyster@gmail.com.
authors.forename: Omar
authors.initials: O
authors.lastname: Ly
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: sowaicha@yahoo.fr.
authors.forename: Aissatou
authors.initials: A
authors.lastname: Sow-Ndoye
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: diabou.diagne@yahoo.fr.
authors.forename: Ndèye Diabou
authors.initials: ND
authors.lastname: Diagne-Gueye
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: didi_sn@yahoo.fr.
authors.forename: Khady
authors.initials: K
authors.lastname: Kébé-Fall
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: fatyraza@hotmail.fr.
authors.forename: Fatou
authors.initials: F
authors.lastname: Diop
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: ayougayediallo@gmail.com.
authors.forename: Aïssatou
authors.initials: A
authors.lastname: Gaye-Diallo
authors.affiliation: 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: prbelecl@yahoo.fr.
authors.forename: Laurent
authors.initials: L
authors.lastname: Belec
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: virus@orange.sn.
authors.forename: Souleymane
authors.initials: S
authors.lastname: Mboup
authors.affiliation: Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal. Electronic address: ctourekane@yahoo.co.uk.
authors.forename: Coumba
authors.initials: C
authors.lastname: Touré-Kane
mesh_terms: D017954:Africa South of the Sahara; D001769:Blood / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis* / Q000235:genetics; D003890:Desiccation; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D019562:Viral Load / Q000379:methods
chemical_list: D004279:DNA, Viral
keywords: CAP/CTM v 2.0; DBS; Early infant diagnosis; HIV-1