Evaluation of the usefulness of Kobias HBsAg and Anti-HBs = Kobias HBsAg/Anti-HBs 시약의 임상적 유용성 평가

Abstract

Background :The analysis of serological markers for hepatitis B virus (HBV) is a useful tool for the prevention and diagnosis of HBV infection. In this work, we evaluated a newly improved domestic rapid assay, Kobias HBsAg and anti-HBs Window kits (Kobias, Korea) for the detection of HBsAg and anti-HBs in serum. Method :A total of 360 sera screened by enzyme immunoassay (EIA) (Enzygnost, DADE Behring, Germany) were included in this study. Each specimen was tested for HBsAg and anti-HBs by Kobias Window kits and Genedia Rapid device (Green Cross, Korea), conventional onestep test kits. The results were compared with those of EIA. Result :The sensitivity and specificity of Kobias HBsAg were 99.2% and 96.7%, and those of Kobias Anti-HBs were 95.8% and 96.7%, respectively. The concordance rates between EIA and Kobias HBsAg and Kobias Anti-HBs were 98.3% and 96.1%, and those between Kobias kits and Genedia kits for HBsAg and anti-HBs were 97.8% and 93.9%, respectively. Conclusion :Genedia kits for HBsAg and anti-HBs were 97.8% and 93.9%, respectively. HBsAg and anti-HBs. With comparable results with EIA, the Kobias HBsAg/Anti-HBs kits could be HBsAg and anti-HBs. With comparable results with EIA, the Kobias HBsAg/Anti-HBs kits could be