Abstract: Objective To investigate the performance of two kinds of magnetic particle chemiluminescence kits for detection of hepatitis B virus surface antigen (HBsAg) and to provide evidence for the diagnosis of hepatitis B.Methods A total of 380 serum and plasma samples were detected for HBsAg confirmation kits produced by Zhengzhou Antu Bioengineering Corporation (test reagent) and Abbott Ireland diagnostics division (control reagent). The performance of 2 kits was analyzed and compared.Results The positive coincidence rate, negative coincidence rate and total coincidence rate of 2 kinds of matching reagents were all 100.00%, which showed the good consistency between the 2 matching reagents (Kappa > 0.75). The positive coincidence rate, the unconfirmed positive coincidence rate and the total coincidence rate of test reagent were 100.00%, 0.00% and 91.58%, respectively. The two confirmation reagents were consistent (Kappa > 0.75); The sensitivity, specificity and accuracy of the test kit were 99.43%, 100% and 100%, respectively. The sensitivity, specificity and accuracy of the control kit were all 100%. There was no significant difference in the diagnostic efficiency between the two kits (P>0.05), and consistency was good (Kappa > 0.75).Conclusion There was no statistically significant difference in the performance between the 2 kits. The HBsAg confirmation kit produced by Zhengzhou Antu Bioengineering Corporation also has high sensitivity and specificity, which can meet clinical detection needs.

Key words: Hepatitis B, Hepatitis B virus surface antigen, Magnetic particle chemiluminescence method, Confirmation Kit, Performance