[Evaluation of 5 kinds of China-made enzyme immuoassay kits for antibody to hepatitis B virus core antigen detection].

Abstract

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

Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBc EIA kit were selected and each detect the anti-HBc panel (95 positive and 57 negative) 5 times. The co/s ratio of each test was recorded and transformed by Ig(co/s+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR=e) 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 A, B, D, C and E, from the best to the worst. And the differences between them were significantly important (Bootstrap method, P < 0.05), except for between kits B and D in CV index; The AUCs ranged from 0.991 to 0.997; For index pAUCs, differences were significant between kits B, D, C ,which had the biggest values, kits A and E which had the lowest ones. For index Se(FPR=e), significant differences were only seen between kits B and A, and B and E (Bootstrap method, P < 0.05).

Conclusion: The diagnostic ability of all the 5 kinds of kits arrange in an order of B, C, D, A and E, from the best to the worst.