全自动ELISA系统检测抗线粒体M2抗体及临床意义

Automatic ELISA system for the detection of anti-mitochondrial M2 antibody and its clinical significance

目的使用全自动酶联免疫吸附试验（ELISA）系统检测抗线粒体M2抗体并探讨其临床意义。方法收集267例血清样本,包括112例原发性胆汁性肝硬化患者（PBC）、77例乙型肝炎病毒（HBV）感染者和78名健康对照者血清样本,使用全自动ELISA系统检测抗线粒体M2抗体,评估该系统检测抗线粒体M2抗体的精密度和抗线粒体M2抗体的临床价值。结果全自动ELISA系统的精密度较好,批内和天间的变异系数（CV）均〈5%。PBC患者抗线粒体M2抗体的阳性率为89.3%（100/112）,抗体浓度值以大于800 RU/m L为主（63%,71/112）。HBV感染者抗线粒体M2抗体的阳性率为5.2%（4/77）,3例抗体浓度值在25~100 RU/mL之间,1例在100 RU/mL以上;健康对照组中抗线粒体M2抗体阳性率为5.1%（4/78）,4例抗体阳性者抗体浓度值均在25~50 RU/mL之间。结论抗线粒体M2抗体ELISA检测的系统化保证了检验结果的稳定性,可为PBC的诊断和与其他肝病的鉴别诊断提供更有价值的实验室依据。

Objective To detect anti-mitochondrial M2 antibody by automatic enzyme-linked immunosorbent assay（ ELISA） system and to investigate its clinical significance. Methods A total of 267 serum samples[（ 112 samples from patients with primary biliary cirrhosis（ PBC）,77 samples from patients infected with hepatitis B virus（ HBV） and 78 samples from healthy controls] were detected for anti-mitochondrial M2 antibody by automatic ELISA system. The precision and the clinical significance of detecting anti-mitochondrial M2 antibody were evaluated. Results The precision was good. The within-run and inter-day coefficients of variation（ CV） were 〈 5%. The patients with PBC had positive rate 89. 3%（ 100 /112） for anti-mitochondrial M2 antibody,usually in high levels（ 〉 800 RU / m L,63%,71 /112）. The positive rate of anti-mitochondrial M2 antibody was 5. 2%（ 4 /77） in patients with HBV infection,including 3cases of 25-100 RU / m L and 1 case of 〉 100 RU / m L,and it was 5. 1%（ 4 /78） in healthy subjects. Conclusions Automatic ELISA system for the detection of anti-mitochondrial M2 antibody guarantees the stability of results. It will provide valuable laboratory reference for the diagnosis of PBC and the differential diagnosis for other liver diseases.