Sensitivity and specificity of 4 domestic ELISA kits for detection of hepatitis B virus markers
10.3321/j.issn:0254-6450.2008.09.015
- VernacularTitle:对四种国产乙型肝炎酶联免疫试剂盒的灵敏度和特异度分析
- Author:
Xing WU
1
;
Cheng ZHOU
;
Wei-Jin HUANG
;
Zibai QI
;
Zheng-Lun LIANG
;
He-Min LI
;
Hui ZHUANG
Author Information
1. 中国药品生物制品检定所
- Keywords:
Hepatitis B virus;
Diagnostic kits;
ELISA
- From:
Chinese Journal of Epidemiology
2008;29(9):915-918
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare and analyze the sensitivity,specificity of 4 domestic ELISA kits for detection of hepatitis B virus (HBV) markers (HBsAg,anti-HBs,HBeAg,anti-HBe,and anti-HBc).Methods Five hundred and ninety four serum samples collected from patients with chronic hepatitis B and abnormal blood donors were detected for HBV markers and by 4 domestic ELISA kits.Samples with conflicting results by different diagnostic kits were retested.Samples with the HBsAg values close to the cut-off point were detected by Abbott HBsAg confirmation kit (Architect HBsAg confirm).Sensitivity of the kits was determined,using the national sensitivity reference panels for HBsAg,anti-HBs,HBeAg,anti-HBe and anti-HBc.Results The rates of sensitivity on 4 domestic kits for detection of HBsAg were 4 to 10 times lower,and on the 4 domestic kits for detection of anti-HBs,HBeAg,anti-HBc and anti-HBc were 4 to 16 times lower,as compared to Abbott Architect kits.In addition,the domestic HBV ELISA kits had some false positive results.The total coincidence rates of HBsAg,anti-HBs,HBeAg,anti-HBe,anti-HBc were 96.46%-98.15%,94.28%-98.15%,98.15%-99.49%,90.07%-96.30%,92.09%-96.80%,respectively.Conclusion Both sensitivity and specificity of the domestically produced HBV ELISA kits should be improved.
