2010年全国自身抗体检测质量控制总结  

The results of quality control of national autoantibody testing in 2010

作　　者：谢瑶[1] 吴琨[2] 彭清林[2] 张荣富[2] 王国春[2] 

机构地区：[1]北京协和医学院研究生院,100005 [2]卫生部中日友好医院风湿免疫科

出　　处：《中华风湿病学杂志》2011年第12期811-815,共5页Chinese Journal of Rheumatology

基　　金：卫生部中日友好医院重点学科建设项目（ZDXK-ZM02-01）

摘　　要：目的了解2010年我国自身抗体检测的现状，促进我国自身抗体检测水平的提高。方法以自愿报名的方式确定参与单位，质量控制的项目包括抗核抗体、抗双链DNA（dsDNA）抗体、抗可提取核抗原（ENA）抗体、抗线粒体抗体（AMA）/抗平滑肌抗体（ASMA）和抗环瓜氨酸肽（CCP）抗体5项，共15个标本。标本发放及结果分析采取双盲的操作。以质量控制标本的揭盲结果为主要评判依据。结果108家医院或科室参加了这次质量控制活动，抗核抗体、抗dsDNA抗体、AMA、ASMA、抗CCP抗体检测的正确率分别是82％、83％、95％、96％、86％。抗RNP抗体、抗Sm抗体、抗SSA抗体、抗SSB抗体、抗Scl-70抗体的正确率分别是84％，95％，98％，98％，88％。但不同实验室间接免疫荧光法检测抗核抗体的滴度及酶联免疫吸附测定法检测抗CCP抗体、抗dsDNA抗体的定量结果差异较大。结论参与质量控制的科室逐年增多，各种抗体检测的方法也逐渐多元化。与此前的全国质量控制结果相比，抗核抗体、抗dsDNA抗体检测的准确率相近，AMA／ASMA、抗CCP抗体的准确率较好，抗ENA抗体检测质量还有待进一步提高。Objective To investigate the quality of autoantibody testing around the whole country. Methods Laboratories that perform autoantibody testing were recruited by letters or telephone eommunieations. The auto-antibodies examined by the quality-control survey included anti-nuclear antibody （ANA）, anti-double-stranded DNA （anti-dsDNA） antibody, anti-extractable nuclear antigens （anti-ENA）, antimitochondria antibody （AMA）, anti-smooth muscle antibody （ASMA）, and anti-citrulline antibody （CCP）. Each autoantibody was tested for 3 samples, so 15 samples were tested in total. Sample distribution and data analysis were double-blinded. Qualitative interpretation, staining patterns were evaluated by IIF. The agree- ment with qualitative interpretation for each specimen was evaluated by ELISA, and Immuno-Blot/Dot-Blot. Results One hundred and eight laboratories participated in this study. The testing methods included indirect immumoiluorescence （IIF）, immuno-Blot （IB）, Dot-Blot （DB）, double diffusion method （DID）, enzyme- linked immunosorbent assay （ELISA）, chemo-illuminescent assay, Dot-immunogold filtration assay. The accuracy rates were 82%, 83%, 95%, 96%, 86%, respectively for ANA, anti-dsDNA, AMA, ASMA, and anti-CCP antibody. Anti-ENA were further divided into anti-SNP, anti-Sin, anti-SSA, anti-SSB, anti-Sel- 70 subgroups, and the accuracy rates were 84%, 95%, 98%, 98%, 88%, respectively. The distribution of quantitative values by different laboratories for ANA （by IIF）, anti-dsDNA, anti-CCP antibody （by ELISA） varied remarkabiy. Conclusion Hospitals that enrolled in the survey and the items involved for quality control were increasing year by year. The accurate rates of ANA, anti-dsDNA in this survey were similar to the past national quality control surveys, the quality of AMA/ASMA, anti-CCP antibodies test was better than that of the past surveys, but the quality of anti-ENA antibodies test needs to be improved.

关 键 词：自身抗体 质量控制 免疫学试验 

分 类 号：R446.6[医药卫生—诊断学]