Access anti-HAV

The Access anti-HAV assay is a chemiluminescent immunoassay that detects total antibodies (IgG and IgM) to hepatitis A virus in human serum and plasma samples using the DxI 9000 analyzer. It is indicated as an aid in diagnosing current or past HAV infection in persons with risk factors or symptoms, identifying HAV-susceptible individuals, and determining antibody response to vaccination.

The Access anti-HAV uses a two-step competitive immunoassay with automated chemiluminescence detection on the DxI 9000 analyzer, compared to the predicate's electrochemiluminescence on cobas e 601. The candidate requires a larger sample volume (55 μL vs. 20 μL), has a longer time-to-result (41 minutes vs. 18 minutes), uses one-level calibration vs. two-level, and has shorter onboard stability (21 days vs. 8 weeks) and calibration frequency (28 days vs. 8 weeks). Both use the same international standard for traceability and qualitative reporting.

CLSI EP05-A3 (precision), CLSI EP07-A3 (interference), CLSI EP09c 3rd Edition (matrix equivalence), CLSI EP10-A3 AMD (carryover), CLSI EP25-ED2 (stability), CLSI GP44-A4 (sample handling). The device also references the Class II Special Controls Guidance Document for Hepatitis A Virus Serological Assays (Feb. 9, 2006).

Both assays detect the same analyte (anti-HAV antibodies) using competitive immunoassay principles with automated detection and identical sample types, anticoagulants, intended indications, and clinical populations. Clinical performance studies demonstrate equivalent sensitivity and specificity: adult cohort achieved 98.5% PPA and 98.9% NPA; pediatric cohort achieved 100% PPA and NPA. Analytical studies show no cross-reactivity (except one HSV-1 sample), no hook effect, acceptable imprecision, and matrix equivalence across serum and plasma types. These performance characteristics closely match the predicate despite differences in instrumentation, timing, and calibration frequency.