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

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-HBe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.然后用上述试剂盒榆测HBV 5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HBsAgELISA试剂盒的灵敏度低4～10倍;抗-HBs、HBeag、抗.HBe和抗-HBc ELISA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.

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-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.