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

Sensitivity and specificity of 4 domestic ELISA kits for detection of hepatitis B virus markers

目的比较4种国产乙型肝炎（乙肝）ELISA试剂盒的灵敏度和特异度。方法取慢性乙肝患者和不合格献血员血液样本594份，应用4种国产乙肝ELISA试剂盒检测HBsAg、抗-HBs、HBeAg、抗-Hge和抗-HBc，并与1种国外乙肝化学发光试剂盒（Abbott公司Architect）比较，对结果不一致的样本再用各试剂盒做双孔重复检测，对HBsAg临界值附近的样本用Abbott HBsAg确证试剂盒（Architect HBsAg confirm）验证；以Abbott试剂盒（Architect）的检测结果为标准，计算4种国产ELISA试剂盒的灵敏度、特异度、总符合率和约登指数。然后用上述试剂盒检测HBV5项标志物的灵敏度参比品，比较不同试剂盒的灵敏度。结果与Abbott公司Architect试剂盒相比，国产IqBsAg ELISA试剂盒的灵敏度低4～10倍；抗-HHs、HBeAg、抗-HHe和抗-HBcELISA试剂盒的灵敏度低4～16倍；且有假阳性。HBsAg、抗-HBs、HBeAg、抗-HBe和抗-HBc的总符合率分别为96．46％～98，15％、94．28％～98．15％、98．15％～99，49％、90.07％～96．30％、92.09％～96．80％。结论国产乙肝ELISA试剂盒的灵敏度和特异度有待进一步提高。

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.