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Performance evaluation of the ADVIA Centaur((R)) HIV Ag/Ab Combo assay.

00:40 EDT 26th May 2013 | BioPortfolio

Summary of "Performance evaluation of the ADVIA Centaur((R)) HIV Ag/Ab Combo assay."

Early diagnosis of HIV infection and appropriate care reduces morbidity and mortality. As a result, recent guidelines recommend that HIV screening be routinely included in patient care. Routine screening will likely result in more patients being tested prior to seroconversion; fourth-generation assays can facilitate diagnosis in these patients. This study evaluated the performance of the automated fourth-generation ADVIA Centaur((R)) HIV Ag/Ab Combo assay. Samples from three sites were tested using the HIV Ag/Ab Combo assay and a CE-marked predicate assay. The HIV Ag/Ab Combo assay's relative sensitivity was 98.36% (599/609; 95% confidence interval: 97.00%-99.21%), and the relative specificity was 99.74% (7743/7763; 95% confidence interval: 99.60%-99.84%). The HIV Ag/Ab Combo assay detected seroconversion at the same bleed or at least one bleed earlier in 34/37 panels compared to the CE-marked predicate assay. Compared to the final result, the HIV Ag/Ab Combo assay's sensitivity was 100% (598/598; 95% confidence interval: 99.39%-100.00%), and the specificity was 99.74% (7753/7773; 95% confidence interval: 99.60%-99.84%). Sensitivity was 100% for the HIV genotypes tested. The HIV Ag/Ab Combo assay is a sensitive and specific assay that can assist clinicians in the early diagnosis of HIV infection.

Affiliation

University of Barcelona\Fundacion Clinic, Barcelona, Spain.

Journal Details

This article was published in the following journal.

Name: Journal of virological methods
ISSN: 1879-0984
Pages:

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Medical and Biotech [MESH] Definitions

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