[Evaluation of 5 kinds of China-made enzyme immunoassay kits for antibody to hepatitis B virus surface antigen detection]

Abstract

Objective: To Screen an EIA kit that fits best for using in serological detection of anti-HBs in the national investigation of hepatitis B virus infection.

Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBs EIA detection kits were selected and each was detected the anti-HBs panel(44 positive and 108 negative) 5 times. The s/n ratio of each test was recorded and transformed by log(s/n+1). ICC and CV, the reliability indices and AUC, pAUC and Se(FPR=e), the validity indices were calculated and compared between each kit.

Results: The indices of ICC and CV of the 5 kinds of kits arranged in the same order of D, E, B, C and A, from the best to the worst and the differences between them were significantly important (Bootstrap method, P < 0.05), except for between E and B in the index of CV; the AUCs ranged from 0.980 to 0.993 and pAUCs did not differ with each other, except with kit A, the lowest one. Kit E had the highest sensitivity which was higher than kits B, C and D when the specificity was fixed at 0.97, and the later kits were higher than kit A(Bootstrap method, P < 0.05).

Conclusion: All the 5 kits are excellent and have synthetically considered the reliability and validity indicators and its function, kit D is the best.