3种检测方法在原发性胆汁性胆管炎相关自身抗体谱中的检测性能评价  

Evaluation of the performance of three detection methods in the autoantibodies associated with primary biliary cholangitis

作　　者：吕松琴 段洪芬 李光敏 张娟 徐丽萍 许宝妹 黄山 Lyu Songqin;Duan Hongfen;Li Guangmin;Zhang Juan;Xu Liping;Xu Baomei;Huang Shan(Clinical Center,Kunming Third people’s Hospital,Yunnan Clinical Medical Center for Infectious Diseases,Kunming Yunnan 650041,China)

机构地区：[1]云南省昆明市第三人民医院、云南省传染性疾病临床医学中心,云南昆明650041

出　　处：《实用医技杂志》2023年第1期41-44,共4页Journal of Practical Medical Techniques

摘　　要：目的探讨3种检测方法在原发性胆汁性胆管炎(PBC)相关自身抗体谱检测中的应用价值。方法分别收集56例PBC确诊患者及15名体检健康人群血清样本,采用磁微粒化学发光法(国产)、流式荧光发光法(国产)和免疫印迹法(进口)检测抗线粒体M2亚型抗体(AMA-M2)、抗三联体抗体(M2-3E/BPO)、抗多核点抗体(SP100)、跨膜糖蛋白210 kd抗体(gp 210),统计分析3种试剂的检测性能,及2种国产试剂与进口试剂的一致性。结果3种检测方法各检测项都具有很高的特异度和阳性预测值>90%,PBC相关自身抗体中SP100和gp120的敏感度、准确度、阴性预测值<70%;流式荧光发光法M2-3E/BPO和磁微粒化学发光法AMA-M2敏感度、准确度、阴性预测值高于同一方法的SP100和gp210,差异有统计学意义(P<0.05)。磁微粒化学发光法与免疫印迹法AMA-M2阴性符合率43%(6/14),Kappa值=0.486,敏感度75%(42/56)、88%(49/56)与特异度93%(14/15)、100%(15/15),差异无统计学意义(χ^(2)=0.297,0.017,P>0.05),且磁微粒化学发光法AMA-M2检测项曲线下面积为0.930;2种国产试剂与进口试剂各检测项阳性符合率、阴性符合率和总符合率均≥80%,kappa值均>0.6。结论2种国产试剂与进口试剂具有较高的一致性,还具备检测时长短、自动化程度高、价格较低等优势,应用前景广阔。Objective To explore the application value of three kinds of detection methods in the detection of autoantibodies related to primary biliary cholangitis.Methods Serum samples were collected from 56 patients with primary biliary cholangitis and 15 healthy people undergoing medical check-ups respectively.Anti-mitochondrial M2 antibodies(AMA-M2),anti-triad antibody(M2-3E/BPO),anti-multinuclear antibody(SP100)and transmembrane glycoprotein 210kd antibody(gp210)were detected by magnetic particle chemiluminescence(domestic),fluorescence radiation(domestic)and Western blotting(imported).The consistency between the two domestic reagents and imported reagents,as well as the diagnostic value of these reagents in primary biliary cholangitis were analyzed statistically.Results As for the three detection methods,they all come with high specificities and positive predictive values(>90%),and the sensitivity,accuracy,and negative predictive value of PBC-related autoantibodies were<70%for SP100 and gp120;the sensitivity,accuracy and negative predictive value of M2-3E/BPO and AMA-M2 were significantly higher than those of Sp100 and gp210 respectively,and the difference was of statistical significance(P<0.05).The negative coincidence rate of AMA-M2 between magnetic particle chemiluminescence and Western blotting was 43%(6/14)and kappa value(0.486)was not high,but the sensitivity was 75%(42/56)and 88%(49/56),which was equivalent to the specificity of 93%(14/15)and 100%(15/15),and the difference was not statistically significant(χ^(2)=0.297,0.017,P>0.05).The area under the AMA-M2 ROC curve of magnetic particle chemiluminescence method was 0.930;the other two domestic reagents and imported reagents had high positive coincidence rate,negative coincidence rate and total coincidence rate(≥80%),and the kappa value was greater than 0.6.Conclusion The two domestic reagents have high consistency with imported reagents,and have the advantages of short detection time,high degree of automation and low which are promising for application.

关 键 词：胆管炎 自身抗体 免疫印迹法 

分 类 号：R575.7[医药卫生—消化系统]