不同免疫方法检测原发性胆汁性胆管炎特异性自身抗体的对比研究

The comparison of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis

目的比较不同免疫学检测方法对抗线粒体2型抗体（AMA－M2）、抗糖蛋白210抗体（anti－gp210）和抗核蛋白体100抗体（anti－sp100）等原发性胆汁性胆管炎（PBC）特异性自身抗体的检测性能。方法2015年4月到2017年4月期间，共收集北京佑安医院就医的91例PBC、67例肝脏疾病对照（包括病毒性肝炎、自身免疫性肝炎、肝硬化等）和40名健康体检对照的血清样本，应用化学发光法（CLIA）和酶联免疫吸附法（ELISA）平行检测AMA－M2，同时采用CLIA和线性免疫印迹法（LIA）检测anti－gp210和anti－sp100。不同方法之间一致性比较采用Kappa检验。CLIA和ELISA检测AMA－M2对PBC诊断准确度的比较则采用受试者工作特征曲线（ROC曲线）。结果CLIA与ELISA检测AMA－M2的总符合率为88.4% （Kappa＝0.765，P〈0.01）。而CLIA与LIA检测anti－gp210和anti－sp100的总符合率分别为96.5%（Kappa＝0.852，P〈0.01）和98%（Kappa＝0.884，P〈0.01）。ROC曲线分析显示CLIA和ELISA检测AMA－M2曲线以下面积（AUC）分别为0.965（P〈0.01）和0.928（P〈0.01）。结论应用CLIA和ELISA在检测AMA－M2时，两种方法具有良好符合率和一致性。而CLIA和LIA在检测anti－gp210和anti－sp100时，同样表现出良好的符合率和一致性。（中华检验医学杂志，2018, 41：203－207）

ObjectiveTo compare the test performance of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis, including anti-mitochondrial type 2 antibody （AMA-M2）, anti-glycoprotein 210 （anti-gp210） and anti-nuclear body protein sp100 （anti-sp100）.MethodsSerum samples from Primary Biliary Cholangitis （PBC, n=91）, liver disease control （including viral hepatitis, autoimmune hepatitis and liver cirrhosis, n=67） and healthy individual （n=40） were collected from Beijing Youan Hospital during the period between April 2014 and April 2017. All samples were tested with chemiluminescent immunoassay （CLIA） and enzyme linked immunosorbent assay （ELISA） for AMA-M2, meanwhile the detection on anti-gp210 and anti-sp100 were compared between CLIA and Line Immunoassay （LIA）. The Kappa coefficient were used to measure the level of qualitative agreement between different assays. The diagnostic accuracy of AMA-M2 detected with CLIA and ELISA were compared by receiver operating characteristic curve （ROC）.ResultsThe overall qualitative agreement between CLIA and ELISA for the detection to AMA-M2 is 88.4% （Kappa=0.765, P〈0.01）. Excellent qualitative agreement between CLIA and LIA for the detection to anti-gp210 and anti-sp100 was also found with overall agreement as 96.5%（Kappa=0.852, P〈0.01）and 98% （Kappa=0.884, P〈0.01）, respectively. The ROC analysis also showed similar area under the curve （AUC） for CLIA （0.965, P〈0.01） and ELISA （0.928, P〈0.01） on detection to AMA-M2.ConclusionsCLIA and ELISA showed excellent agreement for the detection to AMA-M2. High qualitative agreement between CLIA and LIA was also found when testing anti-gp210 and anti-sp100.（Chin J Lab Med, 2018, 41： 203-207）