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

Abstract

OBJECTIVE To Screen best EIA kit that fits best for using in serological detection of HBsAg in the national investigation of hepatitis B virus infection.

Methods: Top 5 kinds of kits on the best seller list of China-made HBsAg EIA detection reagents were selected and each was detected the HBsAg panel (63 positive and 90 negative) 5 times. The s/n ratio of each test was recorded and transformed by log (s/n+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR-e) were calculated and compared between each of the kits.

Results: The indices of ICC and CV of the 5 kits arranged in the same order of E, C, D, B and A, from the best to the worst, and the differences between them were significantly important (Bootstrap method, P < 0.05); The AUCs ranged from 0.965 to 0.987, and for kits E and B which had the biggest pAUCs, differs significantly from kits A and D (Bootstrap method, P < 0.05). Kit E had the highest Se(FPR-e) which was significantly bigger than kit B (Bootstrap method, P < 0.05).

Conclusion: The 5 kinds of kits are all excellent and kit E is the best.