Performance evaluation of the Abbott next-generation high-sensitivity Anti-HCV Next assay on the Alinity i system

Early detection of hepatitis C virus (HCV) infection is essential to reduce virus transmission and enable timely clinical management. Despite many advances in molecular diagnostics, anti-HCV immunoassays remain central to initial screening and diagnosis. This study evaluated the analytical and clinical performance of the Alinity i Anti-HCV Next assay in comparison with the predecessor Alinity i Anti-HCV assay and, for selected parameters, with the Elecsys Anti-HCV II (seroconversion and dilution sensitivity) and ADVIA Centaur aHCV (dilution sensitivity) assays. The Alinity i Anti-HCV Next assay demonstrated consistently low variability, with within-laboratory coefficients of variation below 5% for positive samples, and high clinical specificity (99.94% in blood donors (n=6220) and 100% in hospitalized patients (n=553)). Both Alinity assays showed 100% sensitivity in the clinical sensitivity cohort (n=574). However, improved sensitivity of the Alinity i Anti-HCV Next assay was observed using 33 seroconversion panels, with earlier detection of anti-HCV antibodies in 19 (58%) panels compared to the predecessor assay, and seroconversion sensitivity performance comparable to the Elecsys Anti-HCV II assay. Dilution sensitivity studies indicated an increased analytical sensitivity for the Alinity i Anti-HCV Next assay, which detected reactivity at higher dilution levels than the comparator assays. Specifically, Anti-HCV Next detected reactivity at up to 1,000-fold greater dilutions than the predecessor Anti-HCV assay. In conclusion, the Alinity i Anti-HCV Next assay demonstrated robust analytical and clinical performance, with improved sensitivity in seroconversion and dilution sensitivity studies, supporting its use for early detection of HCV infection.