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


CONCLUSIONS
The 5 kinds of kits are all excellent and kit E is the best.
Zhang
Yong
Y
State Key Laboratory for Infectious, Chinese Center for Disease Control and Prevention, National Institute for Viral Disease Control and Prevention, Beijing 100052, China.
Wang
Feng
F
Ma
Jing-Chen
JC
D002681:China; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood* / Q000276:immunology; D006515:Hepatitis B virus / Q000737:chemistry / Q000276:immunology; D007124:Immunoenzyme Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000592:standards
D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic