Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay.

A fully automated chemiluminescent microparticle immunoassay (Architect HBsAg QT) was used for the detection and quantitation of hepatitis B surface antigen (HBsAg). The assay is capable of processing up to 800 HBsAg tests per hour. The concentration of HBsAg is determined by utilizing a previously generated Architect HBsAg calibration curve. Architect HBsAg QT sensitivity was found to be around 0.2ng/ml which is equivalent or superior to other known and commercially available enzyme immunoassays and/or chemiluminescent immunoassays. We performed a quantitative study of HBsAg, HBeAg, HBV-DNA and HBV-DNA polymerase in over 733 sera obtained from 43 chronic hepatitis B carriers. Serum HBsAg levels detected by Architect HBsAg QT were found to be higher in HBeAg-positive than in anti-HBe-positive HBV chronic carriers and correlated with the level of serum HBV-DNA and HBV-DNA polymerase.