Evaluation of the clinical performance of the Beckman Coulter Access AbHBsII immunoassay for the detection of hepatitis B surface antibodies.

摘要

BACKGROUND: Hepatitis B virus (HBV) surface antibodies (anti-HBs) testing is useful in various clinical circumstances, including identification of HBV susceptible individuals in pre- and post-vaccination programs. OBJECTIVES: To assess the clinical performance of Beckman Coulter's anti-HBs chemiluminescence immunoassay (Access AbHBsII). STUDY DESIGN: Laboratory performances were evaluated on 1207 routine samples pre-screened with Abbott Axsym anti-HBs assay and divided into three different panels: vaccinated subjects (n=232), subjects with resolved HBV infection (n=150) and negative subjects for anti-HBs (n=825). Sera with discrepant results were resolved by an alternative method and further chart review. RESULTS: The overall concordance between Access and Axsym assays was 95.8%. The relative sensitivity, relative specificity, positive predictive value and negative predictive value were 97.8%, 98.1%, 96%, and 99%, respectively. Of the 51 discrepant results, eight were false negative by Access, fifteen were false positive by Access, including sera from seven pregnant women, two patients with acute leukemia, and four with inflammatory syndromes. CONCLUSIONS: The Beckman Coulter's Access AbHBsII assay displays satisfactory relative sensitivity and specificity performances. The assay has good precision and reliability and is technically simple and fast.