Clinical usefulness of a newly developed high-sensitive hepatitis B surface antigen (HBsAg) assay for monitoring hepatitis B reactivation

Abstract

In order to demonstrate the evaluation of basic assessments and the clinical utility of a fully automated highly sensitive chemiluminescent enzyme immunoassay for detecting hepatitis B surface antigen (Lumipulse Presto HBsAg-HQ), the HBsAg-HQ assay was compared to a conventional assay (HISCL HBsAg). The sensitivity of HBsAg-HQ (0.005 IU/mL) is approximately 6-fold higher than that of HISCL (0.03 IU/mL). The concordance rates between HBsAg-HQ and HISCL for 1,312 clinical sera were 99.6%; 5 samples were positive for only HBsAg-HQ. The specificity of HBsAg-HQ was 99.84% (1,256/1,258). Higher sensitivity of HBsAg-HQ was also confirmed with seroconversion panels and dilution tests of each genotype. Moreover, in 9/13 cases with HBV reactivation, HBsAg-HQ was able to detect HBsAg from the sera undetectable with HISCL, and 3 of them had earlier detection than HBV-DNA. Thus, HBsAg-HQ is more sensitive for detecting occult HBV infection and HBV reactivation in the early phase.