Basic evaluation of HISCL-2000i assay of hepatitis B virus surface antigen

Abstract

We compared the hepatitis B virus surface antigen (HBsAg) assay using HISCL-2000i (HISCL) with those using Architect (Arc) and Lumipulse Prest II (Lum). Good results were obtained using the HISCL assay in terms of simultaneous repeatability, daily precision and minimum detection level. Microfibrin contained in the specimen affected the accuracy of the value obtained using the Lum assay, but not those obtained using the HISCL and Arc assays. The correlation of the values obtained using the HISCL and Arc assays was generally consistent. However, the values obtained using the HISCL assay tend to be higher than those obtained using the Lum assay for the specimens with low HBsAg concentrations, whereas those obtained using the HISCL assay tend to be lower for the specimen with high HBsAg concentrations, suggesting the effect of dilution. In the HBsAg mutant detection test, the detection rate was 100% with the HISCL assay, and the Arc assay could detect all 22 HBsAg mutants tested, but the Lum assay could detect all except the mutant of D144-G145R. These results suggest that the HISCL assay is both sensitive and specific, with the capability to detect various types of HBsAg mutant.