Performance of the DxI 9000 Access immunoassay analyzer for the diagnosis of viral hepatitis B and C

Reliable serological assays are essential for the screening and diagnosis of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. We evaluated the analytical and clinical performance of the DxI 9000 Access Immunoassay Analyzer for detecting HBV and HCV markers using over 1,000 serum and plasma specimens, including seroconversion panels and clinical specimens. Results were compared with those from established platforms, such as the VITROS ECiQ and Alinity i. The Access anti-HCV assay demonstrated 97.5% sensitivity and 97.0% specificity, with slightly delayed detection in some seroconversion panels. The Access HBsAg assay showed high sensitivity (98.8%) and specificity (99.2%), with robust detection of most HBsAg variants. Anti-HBc assays (total and IgM) achieved 100% sensitivity and demonstrated excellent concordance across platforms. Anti-HBs results showed good agreement, with minor discrepancies in samples with a low titer (< 10 mIU/mL). Overall, agreement with the comparator assays ranged from 84.7% to 100%. The Access assays on the DxI 9000 platform demonstrate high analytical and clinical performance for hepatitis B and hepatitis C serological testing, with strong agreement with established systems. These results support the use of the DxI 9000 Access Immunoassay Analyzer in the serological testing of viral hepatitis.