Evaluation of a novel chemiluminescent microplate enzyme immunoassay for hepatitis B surface antigen detection.

Abstract Hepatitis B virus surface antigen (HBsAg) is an important biomarker used in the diagnosis of hepatitis B virus (HBV) infection, but false-negative results are still reported in the detection of HBsAg using commercial assays. In this study, we evaluated the qualitative properties of a novel HBsAg chemiluminescence enzyme immunoassay (CLEIA) assay – WTultra. WHO standard sample dilution series and samples from low-level HBsAg carriers ( p p p  = 0.026) and AxSYM V2 (29 positive, p p p