论文部分内容阅读
目的:分析2016—2018年全国自身免疫性肝病相关自身抗体检测质量调查结果,了解国内相关自身抗体的检测现状,为开展质量评价及指南的制定提供参考数据。方法:参评项目包括抗线粒体抗体(AMA)、抗线粒体抗体M2亚型(AMA-M2)抗体、抗平滑肌抗体(ASMA)、抗SP100抗体和抗GP210抗体。依托中国医院协会网络平台,采用双盲操作,使用Excel软件对检测结果进行统计学分析。结果:质量调查参评单位遍及全国27个省、市、自治区,3年内共225家单位参加:2016年22家,占9.7%;2017年65家,占47.1%;2018年138家,占61.3%。2016—2018年各项检测结果符合率(定性):AMA为97.1%、94.6%和96.7%;AMA-M2抗体为96.9%(2017年)和99.1%(2018年);ASMA为92.4%、94.8%和95.7%;抗GP210抗体为100.0%、97.1%和97.6%;抗SP100抗体为100.0%、99.3%和98.9%。其中2018年调查显示各参加单位的主流检测方法为:AMA为间接免疫荧光法97.1%(101/104);ASMA为间接免疫荧光法100.0%(108/108);抗AMA-M2为免疫印迹法80.9%(110/136);抗GP210抗体为免疫印迹法87.9% (94/107);抗SP100抗体为免疫印迹法88.0%(95/108)。自身免疫性肝病相关自身抗体的检测中,ASMA阳性符合率(定性)最低,分别为:76.2%(2016)、81.5%(2017)和81.5%(2018)。各项目定量方法结果差异较大,未做综合分析。结论:参评单位自身免疫性肝病相关自身抗体检测定性结果符合率较高,其中ASMA的检测符合率仍有待进一步提升。“,”Objective:To investigate the current quality of detection of autoimmune liver disease (AILD) related autoantibodies by reviewing 2016--2018 nation wide survey results. To provide reference data for quality assessment and guidance of such inspection items.Methods:Anti-mitochondrial antibody (AMA), anti-AMA-M2 antibody, anti-smooth muscle antibody (ASMA), anti-GP210 antibody and anti-SP100 antibody were included in the survey. The survey was carried out in a double-blind manner based on the association's network platform. Statistical analysis was performed by Excel software.Results:Institutes participated in the survey covered 27 provinces, cities and autonomous regions in China, including 225 labs participated the survey within 3 years: 22 in 2016, accounting for 9.7%; 65 in 2017, accounting for 47.1%; 138 in 2018, accounting for 61.3%. The accuracy rates of qualitative test during 2016—2018 survey were 97.1%, 94.6% and 96.7% (AMA); 96.9% (2017) and 99.1% (2018) (AMA-M2); 92.4%, 94.8% and 95.7% (ASMA); 100.0%, 97.1% and 97.6% (anti-GP210); 100.0%, 99.3% and 98.9% (anti-SP100), respectively. The major assays for each item in 2018 survey were: AMA 97.1% (101/104) by indirect immunofluorescence assay (IIF), ASMA 100.0%(108/108) by IIF, AMA-M2 80.9%(110/136) by IB, anti-GP210 87.9%(94/107) by immunoblotting (IB), anti-SP100 88.0%(95/108) by IB. In the detection of autoantibodies related to autoimmune liver disease, the positive consistency rate of ASMA (qualitative) was the lowest: 76.2%(2016), 81.5%(2017) and 81.5%(2018), respectively. Due to the great difference in the feedback results of quantitative assays for each item, no comprehensive analysis was made.Conclusion:Laboratories participated in the survey have high accuracy rates of qualitative testing for AILD related autoantibodies. The accuracy rates of ASMA testing by indirect immunofluorescence need to be improved.