CAJ | 학술논문

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.
목적 조사분석중국검측평활기항체(ASMA)화항선립체항체(AMA)공작현상,위개진기검측질량제공의거.방법 조사성연구.공유154가실험실(지소삼가1개항목적검측비대공작)자원보명삼가전국자신면역성간병상관항체검측다중심비대분석.유위생공익성행업과연전항“풍습면역병진료관건기술림상추엄급전화응용연구”항목조(이하칭“항목조”)제비비대양품(액체혈청),포괄5빈ASMA비대양품화5빈AMA(포괄AMA-M2아형항체검측)비대양품,병우2012년12월15일상온하장비대양품발방지각실험실.요구각실험실재2012년12월31일지전안조각자실험실상규방법검측비대양품,병우2013년1월14일전장검측결과이급검측소용방법전입통일표격기회항목조.항목조채용Excel연건대검측결과진행분석,주요포괄부합솔분석화적도회보솔분석.결과 ASMA-1위ASMA양성,여위ASMA음성.AMA-3화AMA-4위AMA급AMA-M2쌍양성,여위AMA급AMA-M2쌍음성.삼가ASMA、AMA화AMA-M2검측비대공작적실험실수목분별위103가、103가화138가.ASMA、AMA화AMA-M2비대품검측결과양성부합솔분별위57.3％、66.5％화93.5％,음성부합솔분별위96.8％、99.0％화97.8％.간접면역형광법시검측ASMA화AMA적주요방법,단해법양성부합솔교저,분별위57.6％화65.2％,차2개항목적적도회보솔역교저,분별위39.1％화43.5％.동시회보AMA화AMA-M2검측결과적실험실점총회보실험실적57.0％.결론 2012년아국림상실험실검측ASMA화AMA비대품적양성부합솔상불이상,음성부합솔교호.AMA-M2검측부합솔균교호.IIF법검측ASMA화AMA적적도회보솔교저.목전극수규범화제고자신면역성간병상관자신항체보검측질량.
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％和1 97.8％,respectively,lndirect 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 39.1％ 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 AMA-M2 are good.The titer report rate of the detection of ASMA and AMA are low by IIF.Standardization and elevation of detecting quality of autoimmune liver disease related autoantibodies are in urgent need of in China.