Clinical usefulness of high-sensitivity quantitative assay of hepatitis B virus surface antigen measured using L2400: Analysis of daily data

Abstract

We investigated the usefulness of hepatitis B virus surface antigen (HBsAg) highly sensitive quantitative reagent “Lumipulse presto HBsAg-HQ (HBsAg-HQ assay)’’ by analyzing daily patient data. Among negative cases (92.05%, 7,857/8,536), the mismatch after retest was 0.04% (3/7,843), and the rate of negative HBsAg suppression test was 0.14% (11/7,843). Among the positive cases, the highly sensitive area was 2.95% (20/679), the rate of negative HBsAg suppression test was 56% (14/25), and 13 cases tested were positive for HBcAb. From these results, we confirmed that the HBsAg-HQ assay has high specificity and can capture HBsAg with high sensitivity. In addition, the results of HBsAg assay and HBV-DNA continuous analysis in two cases of HBV reactivation prevention suggest that the HBsAg-HQ assay is useful for monitoring HBV reactivation.