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

摘要

Objective To 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).Methods Serum 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).Results The 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.Conclusions CLIA 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.%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.