Anti-HCV Next

The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) that qualitatively detects antibodies to hepatitis C virus in human serum and plasma on the Alinity i system. It aids in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women, but is not cleared for screening blood, plasma, or tissue donors.

The subject device uses CMIA technology with a combined one-step/two-step immunoassay approach on the Alinity i platform, compared to the predicate's two-step CLIA methodology on the LIAISON XL Analyzer. Both detect the same analyte (anti-HCV) and use similar specimen types (serum and plasma), but differ in capture antigens, components, calibration storage duration (30 days vs. 8 weeks), and instrument platform.

CLSI EP05-A3 for within-laboratory precision, CLSI EP07 (3rd ed.) for interference testing, and CLSI EP12 (3rd ed.) for clinical percent agreement studies.

The Anti-HCV Next assay demonstrates substantial equivalence through comparable analytical performance (precision, seroconversion sensitivity, specificity across disease states and genotypes 1–6, and resistance to high-dose hook effects) and clinical performance (99.50% positive percent agreement and 97.24% negative percent agreement overall) to the predicate device across three population groups (individuals at risk, symptomatic individuals, and pregnant women).