Fundamental assessment of the chemiluminescent enzyme immunoassay measurement reagent Lumipulse HBsAg-HQ

Abstract

The hepatitis B virus (HBV) surface antigen (HBsAg) is a secreted envelope glycoprotein of HBV. Although a qualitative test of HBsAg is important in the diagnosis of HBV infection, a quantitative assay of HBsAg has recently been used for monitoring during the treatment of chronic HBV infection as well as for the prediction of clinical responses. In this study, we evaluated the new quantitative reagent Lumipulse HBsAg-HQ in terms of its fundamental performance in the testing of HBsAg. Lumipulse HBsAg-HQ showed good performance in terms of within-run and between-day reproducibility and stability against coexistent substances. Compared with the conventional reagent Lumipulse II HBsAg, concordant results were obtained in 98.6% (205/208) of tested samples. The results of an inhibition assay using three samples with discrepant results between the two reagents suggested that Lumipulse HBsAg-HQ showed improved sensitivity. Thus, our data suggest that Lumipulse HBsAg-HQ could provide more accurate and useful information on the HBsAg status for clinicians than Lumipulse II HBsAg.