Access anti-HAV IgM

The Access anti-HAV IgM assay is a chemiluminescent immunoassay that detects IgM antibodies to hepatitis A virus in human serum and plasma samples using the DxI 9000 analyzer. It is intended to aid in the laboratory diagnosis of acute or recent hepatitis A infection in individuals with clinical signs and symptoms, and is not intended for blood donor screening.

The device uses a two-step sandwich immunoassay with paramagnetic particles coated in anti-human IgM monoclonal antibody, chemiluminescent detection, and automated processing on the DxI 9000 platform. Key differences from the predicate include a smaller sample volume (10 µL vs. 70 µL), longer reagent stability after opening (56 days vs. 30 days), and different cutoff thresholds (≥1.00 S/CO reactive vs. ≥1.21 S/CO reactive).

CLSI EP05-A3 (precision evaluation), CLSI EP07-A3 (interference testing), CLSI EP09c (method comparison), CLSI EP10-A3 (qualitative procedure evaluation), CLSI EP25-ED2 (reagent stability), CLSI GP44-A4 (specimen handling), and EN ISO 17511 (traceability standards).

The Access anti-HAV IgM assay demonstrates substantial equivalence to the Abbott ARCHITECT HAVAB-M predicate through identical operating principles (two-step sandwich), same analyte (anti-HAV IgM), qualitative results, chemiluminescent detection, and comparable clinical performance including 100% positive and 99.3% negative percent agreement in the overall study population and 100% PPA/99.1% NPA in pediatric subjects.