Performance evaluation of the access anti-HBc IgM Assay on the DxI 9000 access immunoassay analyzer

This study evaluated the diagnostic and analytical performances of the Access anti-HBc IgM assay (Access assay) for use on the DxI 9000 Access Immunoassay Analyzer. Prospectively and retrospectively collected samples were tested with Access and a comparator assay with use of a second comparator for discrepant resolution to determine final anti-HBc IgM sample status. Specificity of Access was 100.00 % (99.65 - 100.00 %) on 1,098 anti-HBc IgM negative blood donor samples, 100.00 % (98.74 - 100.00 %) on 300 anti-HBc IgM negative hospitalized patient samples and 94.08 % (89.45 - 96.75 %) on 169 anti-HBc IgM negative acute/recent and chronic HBV infected patient samples. Sensitivity was 100.00 % (98.42 - 100.00 %) on 239 anti-HBc IgM positive acute/recent and chronic HBV infected patient samples. Seroconversion panels showed mean first day of detection 3.2 days earlier with Access than with the comparator assay. Maximum reproducibility on positive samples was 8.6 % coefficient of variance (CV) and 0.048 S/CO standard deviation (SD) on negative samples. The Access anti-HBc IgM assay demonstrated excellent diagnostic and analytical performances comparable to other current CE-marked anti-HBc IgM assays.