ArticleJournal of medical virology2026
Comprehensive Evaluation of the Elecsys HCV Duo Immunoassay for Active Hepatitis C Detection: Insights From the DEPCDUO Study.
Article in Journal of medical virology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Early diagnosis of Hepatitis C virus (HCV) infection is a cornerstone of elimination strategies. Fourth-generation antigen/antibody combination assays, such as Elecsys HCV Duo, promise to bridge the diagnostic gap left by antibody-only testing. In this real-world study, we assessed Elecsys HCV Duo performance using seroconversion panels and routine clinical samples, focusing on sensitivity, specificity, and positive predictive value (PPV) for active HCV detection, including challenging scenarios with low viral loads and HIV co-infections. The assay shortened the serological window by up to 203 days. When both antigen and antibody were detected, PPV reached 100%, enabling confident diagnosis without immediate RNA confirmation. The antigen component alone achieved a PPV of 97.6%, even in a low-prevalence setting (0.33%), better than previously reported assays. However, sensitivity for low viral loads (≤ 5 log
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