A-285 Evaluation of a newly developed Access anti-HAV immunoassay on the DxI 9000 Immunoassay Analyzer

Abstract Background Beckman Coulter, Inc. has recently developed a fully automated Access anti-hepatitis A Virus (HAV) assay* for the detection of antibodies to HAV (IgG and IgM) for use on the DxI 9000 Immunoassay Analyzer. The assay*s analytical and clinical performances were evaluated. Methods Imprecision was evaluated using three replicates of eight samples and two quality controls using multiple reagent packs and calibrator lots in 40 runs based on CLSI EP05-A3. Reproducibility was evaluated at three US clinical laboratories using one lot of reagent, low/high negative and positive samples, and quality controls based on CLSI EP05-A3. Cross-reactivity was evaluated using 234 negative samples and a reference method across 22 categories including other viral infection and auto-immune diseases. Access anti-HAV assay sensitivity for early detection was assessed on four seroconversion panels. Access anti-HAV assay clinical diagnostic performance was evaluated in comparison to commercially available FDA-cleared anti-HAV reference assays at three US clinical laboratories to evaluate the assay’s ability as an aid in the diagnosis of current or past HAV infection and to determine the presence of an antibody response to HAV in vaccine recipients. Results Total imprecision demonstrated = 5.9 % CV for samples = 1.00 S/CO, and total standard deviation (SD) = 0.05 for samples < 1.00 S/CO while reproducibility demonstrated an overall imprecision < 8% for samples = 1.00 S/CO (n=360) and an SD of < 0.04 for samples < 1.00 S/CO (n=360). The cross-reactivity study demonstrated overall negative agreement of 99.6% versus the reference assay. Seroconversion testing results demonstrated that the Access anti-HAV assay is equivalent in sensitivity to the reference assay. The Access anti-HAV assay demonstrated overall PPA of 98.8% (n=810/820; 95% CI: 97.8-99.3%) and NPA of 98.5% (n=334/339; 95% CI: 96.6-99.4%) in the diagnostic population. The HAV antibody response to vaccination, i.e. pre- and post- vaccination (n=59), demonstrated PPA and NPA of 100% with a 95% CI of 93.9-100.0%. Conclusion The Access anti-HAV assay demonstrated excellent analytical and clinical performance equivalent to currently FDA-cleared anti-HAV assays. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners. *For Investigational Use only. The Access anti-HAV assay is pending premarket clearance by the United States Food and Drug Administration; not yet available for in vitro diagnostic use in the US.