中国154家实验室检测抗平滑肌抗体和抗线粒体抗体的比对分析  

A multi-center comparison of smooth muscle autoantibodies and mitochondrial autoantibodies in 154 laboratories of China

作　　者：邓垂文[1] 胡朝军[1] 白依娜[1] 董晓娟[1] 李萍[1] 李丽君[1] 宋宁[1] 史艳萍[1] 张奉春[1] 李永哲[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院风湿免疫科风湿免疫病教育部重点实验室,100032

出　　处：《中华检验医学杂志》2014年第2期127-131,共5页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金资助项目（81072486,81172857）;国家十一五科技支撑计划资助项目（2008BAl59803）;卫生公益性行业科研专项（201202004）

摘　　要：目的调查分析中国检测平滑肌抗体（ASMA）和抗线粒体抗体（AMA）工作现状，为改进其检测质量提供依据。方法调查性研究。共有154家实验室（至少参加1个项目的检测比对工作）自愿报名参加全国自身免疫性肝病相关抗体检测多中心比对分析。由卫生公益性行业科研专项“风湿免疫病诊疗关键技术临床推广及转化应用研究”项目组（以下称“项目组”）制备比对样品（液体血清），包括5份ASMA比对样品和5份AMA（包括AMA—M2亚型抗体检测）比对样品，并于2012年12月15日常温下将比对样品发放至各实验室。要求各实验室在2012年12月31日之前按照各自实验室常规方法检测比对样品，并于2013年1月14日前将检测结果以及检测所用方法填入统一表格寄回项目组。项目组采用Excel软件对检测结果进行分析，主要包括符合率分析和滴度回报率分析。结果ASMA-1为ASMA阳性，余为ASMA阴性。AMA．3和AMA-4为AMA及AMA．M2双阳性，余为AMA及AMA—M2双阴性。参加ASMA、AMA和AMA—M2检测比对工作的实验室数目分别为103家、103家和138家。ASMA、AMA和AMA．M2比对品检测结果阳性符合率分别为57．3％、66．5％和93．5％，阴性符合率分别为96．8％、99．0％和97．8％。间接免疫荧光法是检测ASMA和AMA的主要方法，但该法阳性符合率较低，分别为57．6％和65．2％，且2个项目的滴度回报率亦较低，分别为39．1％和43．5％。同时回报AMA和AMA—M2检测结果的实验室占总回报实验室的57．0％。结论2012年我国临床实验室检测ASMA和AMA比对品的阳性符合率尚不理想，阴性符合率较好。AMA—M2检测符合率均较好。IIF法检测ASMA和AMA的滴度回报率较低。目前亟需规范和提高自身免疫性肝病相关自身抗体谱检测质量。（中华硷验医学杂舌，2014，37：127．131）Objective Survey and analyses the current situation of autoantibodies testing of ASMA and AMA in China for evidence of further improvement of detecting quality. Methods Survey study. 154 laboratories （at least participated in one item ） participated voluntarily in the study of multi-center comparison of autoantibodies testing of autoimmune liver diseases. The samples （serum liquid） were prepared by the group of Clinical promotion and translational application research of key technology of diagnosis and treatment of autoimmune diseases of the Research Special Fund for Public Welfare Industry of Health （＂ the group＂ for short）, including 5 ASMA samples and 5 AMA samples （for AMA-M2, too）, which were mailed to laboratories under normal temperature on 15th Dec 2012. The laboratories were required to detect the samples using their routine methods before 31th Dec 2012, and mail the results and methods in a special form back to our group before 14th Jan 2013. The group preformed analysis of the results by Excel, including coincidence rate and titer report rate. Results The reference results of the samples were ASMA-1 positive, others negative, AMA-3 and -4 positive for both AMA and M2, others negative for both AMA and M2. The laboratories that eventually participated in ASMA, AMA and AMA-M2 were 103, 103 and 138, and the positive coincidence rate were 57. 3%, 66. 5% and 93.5%, meanwhile the negative coincidence rate were 96. 8% ,99.0% ~ 97.8%, respectively. Indirect immunofluorescence （IIF） was the most common method for detection of ASMA and AMA, while low positive coincidence rate was found in the testing of ASMA and AMA, 57. 6% and 65.2%, respectively. In addition, only 39. l% and 43.5% labs reported the titer results of ASMA and AMA. About 57.0% of the labs reported results of AMA and AMA-M2 at the same time. Conclusions In 2012, the positive coincidence rate of ASMA and AMA are not satisfying in clinical labs of China, while the negative coincidence rate of them and the coincidence rate of A

关 键 词：肝炎 自身免疫性 肝硬化 胆汁性 肌 平滑 线粒体 自身抗体 

分 类 号：R446.6[医药卫生—诊断学]