Abstract: Objective To investigate the efficacy of serum HBsAg by two quantitative methods in predicting liver histopathological grading and staging in patients with chronic hepatitis B. Methods 132 HBeAg-positive and 115 HBeAg-negative patients with chronic hepatitis B,who had underwent liver biopsy,were enrolled in the present study. Liver histopathological diagnosis was made with reference to the Scheuer scoring system and serum HBsAg levels were detected by Maccura IS1200 （HBsAg-IS1200） and by Architect I2000 （HBsAg-I2000）. Results In both HBeAg-positive and HBeAg-negative patients,HBsAg-IS1200 was significantly positively correlated with HBsAg-I2000（r=0.937,P<0.0001 and r=0.964,P<0.0001）,and had a close linear correlation with HBsAg-I2000（F=935.970,P<0.0001 and F=1496.884,P<0.0001）;according to ROC curve analyses,both HBsAg-IS1200 and HBsAg-I2000 had significant predictive values for pathologic grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P<0.005） in HBeAg-positive patients,and both HBsAg-IS1200 and HBsAg-I2000 had no significant predictive values for pathologic grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P>0.05） in HBeAg-negative patients; there were no significant differences in all the areas under ROC curves between HBsAg-IS1200 and HBsAg-I2000 in predicting pathological grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P>0.05） in both HBeAg-positive and HBeAg-negative patients, with reference to the optimal cut-off value based on the maximum Youden indexes,the results between HBsAg-IS1200 and HBsAg-I2000 in predicting the liver pathological grade ≥G2,≥G3 and stage ≥S2,≥S3,≥S4 had high or very high consistency （Kappa=0.7243,Kappa=0.6967 and Kappa=0.8438,Kappa=0.8308,Kappa=0.7097） in HBeAg-positive patients. Conclusion HBsAg-IS1200 is highly consistent with HBsAg-I2000 in predicting liver histopathological grading and staging in patients with chronic hepatitis B.

Key words: Hepatitis B, HBsAg, Chemiluminescence immunoassay, Liver biopsy, Noninvasive diagnosis