[Sensitivity and specificity of 4 domestic ELISA kits for detection of hepatitis B virus markers].
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-HBe 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.


CONCLUSIONS
Both sensitivity and specificity of the domestically produced HBV ELISA kits should be improved.
Wu
Xing
X
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Zhou
Cheng
C
Huang
Wei-Jin
WJ
Qi
Zi-Bai
ZB
Liang
Zheng-Lun
ZL
Li
He-Min
HM
Zhuang
Hui
H
D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D012680:Sensitivity and Specificity
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic