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.

journal_name

J Virol Methods

authors

Gueye SB,Diop-Ndiaye H,Diallo MM,Ly O,Sow-Ndoye A,Diagne-Gueye ND,Kébé-Fall K,Diop F,Gaye-Diallo A,Belec L,Mboup S,Touré-Kane C

doi

10.1016/j.jviromet.2015.12.006

subject

Has Abstract

pub_date

2016-03-01 00:00:00

pages

12-5

eissn

0166-0934

issn

1879-0984

pii

S0166-0934(15)00390-0

journal_volume

229

pub_type

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