Evaluation and application of a newly developed highly sensitive HBsAg chemiluminescent enzyme immunoassay for chronic hepatitis B patients

AIM: A high sensitive chemiluminescent enzyme immunoassay (CLEIA) was developed for quantitative hepatitis B surface antigen (HBsAg) detection by a combination of monoclonal antibodies, each one for a specific epitope of HBsAg, and by improving the conjugation technique (Matsubara, et al. Transfusion 2009). We modified and automated Matsubara's techniques. Our aim is to evaluate the fundamental performance of our assay (prototype) and to investigate the clinical significance of prototype in patients with hepatitis B virus (HBV) infection. METHODS: We used 226 HBsAg-negative samples and 59 HBsAg-positive samples for evaluation of prototype's accuracy, reproducibility, specificity and sensitivity. We examine correlation between the prototype assay and commercial quantitative HBsAg detection assay (the Abbott ARCHITECT). Performance of prototype was compared with the Abbott ARCHITECT in one chronic hepatitis B patient and one patient with HBsAg seroconversion sequentially. RESULTS: The prototype assay had good accuracy, reproducibility, specificity and sensitivity. There is positive correlation between the prototype and the Abbott ARCHITECT. The sensitivity of the prototype (5 mIU/mL) was approximately 10 fold higher than the Abbott ARCHITECT (50 mIU/ml). The prototype could detect HBsAg at the HBsAg-negative point by Abbott ARCHITECT in these patients. CONCLUSIONS: Automatic highly sensitive HBsAg CLEIA prototype is convenient and precise assay for HBV monitoring.