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


CONCLUSIONS
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.
Ma
Jing-Chen
JC
Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.
Qi
Shun-Xiang
SX
Wang
Feng
F
D002681:China; D006509:Hepatitis B / Q000097:blood* / Q000175:diagnosis / Q000276:immunology / Q000821:virology; D006510:Hepatitis B Antibodies / Q000097:blood* / Q000276:immunology; D006512:Hepatitis B Core Antigens / Q000032:analysis / Q000276:immunology*; D006515:Hepatitis B virus / Q000737:chemistry / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D011933:Reagent Kits, Diagnostic