出 处:《中华风湿病学杂志》2024年第11期803-807,I0002,共6页Chinese Journal of Rheumatology
基 金:浙江省医药卫生科技计划(2022KY384);嘉兴市科技计划项目(2024AD30109)。
摘 要:目的分析评价临床不同检测方法检测抗线粒体抗体(AMA)对原发性胆汁性胆管炎(PBC)的诊断性能。方法回顾性分析2022年11月至2023年11月就诊于嘉兴市第二医院PBC患者37例,同期43例其他自身免疫病患者以及53名健康对照组的血清样本,用间接免疫荧光法(IIF)、免疫印迹法(IB)以及磁微粒化学发光法(CLIA)平行检测AMA的结果。组间比较采用Fisher精确检验和配对χ^(2)检验。运用韦恩图分析3种检测结果一致性分布,通过各自受试者工作特征曲线(ROC)下面积评价对PBC诊断性能。结果在PBC组AMA阳性检出率显著高于另外2组,其中在CLIA法的阳性检出率最高(86.5%,32/37)。韦恩图中显示3种方法学检测AMA结果一致的比例为74.4%(99/133),IB与CLIA法检测抗线粒体抗体2型(AMA-M2)结果一致的比例为86.5%(115/133)。3种方法学检测性能对比,特异度最高是IIF法(92.7%),灵敏度最高的是CLIA法(86.5%)。IIF法、IB法以及CLIA法的AUC分别是0.801、0.800以及0.875;联合检测中,IIF+CLIA法的AUC是0.942且优于其他两者或者三者联合检测。结论对筛查实验IIF法AMA阴性疑似PBC患者,可以联合采用IB法或者CLIA法检测AMA-M2;建议临床医生参考2~3种方法学检测的AMA结果,并优先推荐IIF法联合CLIA法检测AMA。Objective To analyze and evaluate the different methods in detecting anti-mitochondrial antibodies(AMA)for the diagnostic performance of primary biliary cholangitis(PBC).Methods In this retrospective study,we collected serum samples of 37 PBC patients who were admitted to the Second Hospital of Jiaxing,from November 2022 to November 2023,43 patients with other autoimmune diseases and 53 normal controls during the same time.The results of AMA were detected in parallel by indirect immunofluorescence assay(IIF),immunoblot tests(IB)and chemilluminescent microparticle immunoassay(CLIA).Fisher′s exact test was used to compare the count data between different groups,while a paired chi-square test was used to assess the results of the three test methods.We analyzed the performance of the three test methods;Venn diagram was used to show the consistency distribution of AMA results,the diagnostic performance of AMA for PBC were evaluated by area under receiver operating characteristic curve(ROC).Results The positive rate of AMA in PBC group was significantly higher than that in the other two groups,and AMA was detected by CLIA which had higher positive rate(86.5%,32/37)than the other two methods.As shown in the Venn diagram,the proportion of consistent AMA results among the three methods was 74.4%(99/133),and between IB and CLIA methods which used for detecting AMA-M2,the consistent proportion was 86.5%(115/133).Among comparison of the performance of three methods,the highest specificity(92.7%)was IIF method,and the highest sensitivity(86.5%)was CLIA method.The respective AUC of IIF,IB and CLIA methods were 0.801,0.800 and 0.875.In the combined detection,the AUC of IIF+CLIA method was 0.942,which was better than the other two or triple combined method detection.Conclusion For highly suspected PBC patients with negative IIF screening test,combined IB or CLIA could be used to detect AMA-M2.We recommended that clinicians should refer to the AMA results conducted by two or three methods,and preferentially recommended the IIF
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