A lateral flow immunoassay combining HCV antigen and antibody detection for improved early diagnosis

Background: Rapid and accurate detection of hepatitis C virus (HCV) infection is essential for early diagnosis, timely intervention, and cost-effective disease management. Conventional antibody-based assays may fail to detect infection during the acute phase, highlighting the need for diagnostic tools capable of identifying both HCV antibodies and antigens. Methods: A total of 2501 serum and plasma specimens (778 HCV-positive, 1723 HCV-negative) were evaluated using the ASSURE HCV Ab/Ag Rapid Test. Diagnostic performance was assessed against reference assays, including an independent clinical evaluation in Malaysia. Analytical sensitivity, cross-reactivity, interference, seroconversion performance and specimen equivalency were also examined. Results: The assay demonstrated 100% sensitivity (778/778), 99.83% specificity (1720/1723), and near-perfect agreement with reference assays (Kappa = 0.998). Analytical evaluation confirmed robust antibody and antigen detection across serial dilutions. No cross-reactivity was observed across 30 antibody panels, and no interference was detected from 19 endogenous or exogenous substances. Seroconversion analysis identified infection ∼17 days earlier than antibody-only comparators. Performance was fully equivalent across serum, plasma, venous whole blood, and finger-prick whole blood. Conclusions: The ASSURE HCV Ab/Ag Rapid Test demonstrated high sensitivity and specificity for HCV screening, combining antibody and antigen detection to support earlier diagnosis including acute-phase infections, though prospective real-world validation is warranted before population-level deployment.

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