A single-center, single-blind study to evaluate the clinical sensitivity, specificity, and agreement between Elecsys Anti-HBc II and Elecsys Anti-HBc in a Korean population.

BACKGROUND: Anti-HBc IgG is almost always detected in hepatitis B virus (HBV)-infected individuals and persists in resolved infections. In certain cases, anti-HBc IgG is the only serological marker and anti-HBc-positive result generally means anti-HBc total positivity.

OBJECTIVES: To evaluate the clinical sensitivity and specificity of an investigational medical device, Elecsys Anti-HBc II, using samples from the Korean population. Agreement between Elecsys Anti-HBc II and its widely utilized predecessor Elecsys Anti-HBc was also evaluated.

STUDY DESIGN: Residual serum or plasma samples stored at below -20 °C without individual identifiers were used in this study. This study had 106 randomly selected HBV deoxyribonucleic acid (DNA)-positive samples used for evaluating clinical sensitivity. For clinical specificity, a total of 239 both HBV DNA and hepatitis B surface antigen-negative samples, which were anti-HBc-negative by Elecsys Anti-HBc, were used. Agreement between Elecsys Anti-HBc and Elecsys Anti-HBc II was evaluated in total 345 samples. The Architect Anti-HBc II was used as a confirmatory test regarding discrepancies between Elecsys Anti-HBc and Elecsys Anti-HBc II results.

RESULTS: The clinical sensitivity and specificity of Elecsys Anti-HBc II were found to be 99.06% and 100%, respectively. In total, 345 samples showed 100% agreement. Both positive and negative agreements were also 100%.

CONCLUSIONS: The clinical performance of Elecsys Anti-HBc II was confirmed as sufficient in Korean samples. Elecsys Anti-HBc II demonstrated an exceptional performance, exceeding the requirements of the Ministry of Food and Drug Safety and confirming its reliability as an in vitro diagnostic device for HBV diagnosis in Korea.