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  • Title: [Sensitivity and specificity of 4 domestic ELISA kits for detection of hepatitis B virus markers].
    Author: Wu X, Zhou C, Huang WJ, Qi ZB, Liang ZL, Li HM, Zhuang H.
    Journal: Zhonghua Liu Xing Bing Xue Za Zhi; 2008 Sep; 29(9):915-8. PubMed ID: 19173858.
    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-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. CONCLUSION: Both sensitivity and specificity of the domestically produced HBV ELISA kits should be improved.
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