健康与遗传心理学研究室知识库

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.