2011年全国多中心自身抗体检测质量控制结果分析  

Summary of the 2011 national autoantibody testing quality control

作　　者：姚海红[1] 贾汝林[1] 贾园[1] 栗占国[1] 

机构地区：[1]北京大学人民医院风湿免疫研究所/临床免疫中心,100044

出　　处：《中华风湿病学杂志》2012年第12期825-829,共5页Chinese Journal of Rheumatology

摘　　要：目的了解2011年我国自身抗体检测的现状，以规范和促进我国自身抗体检测水平。方法在全国范围内确定参与单位，质量控制的项目共计6项，15个标本，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，其中AMA、ASMA所用标本相同。标本发放及结果分析采取双盲的操作。共114个单位参加了此次质量控制活动，采用的检测方法包括间接免疫荧光法（IIF）、免疫印迹法（IB）、斑点法（DB）、免疫扩散法（DID）、酶联免疫吸附试验（ELISA）、化学发光法、胶体金斑点渗滤法等。结果抗核抗体、抗dsDNA抗体、抗ENA抗体、AMA、ASMA、抗CCP抗体检测的正确率分别是98．0％、96．6％、89．5％、98．1％、92．1％和96．4％。其中抗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88．4％、96．8％、100％、100％和95．8％。不同实验室间IIF法检测抗核抗体的滴度差异较大，但核型判定符合率较以往增高。此外，ELISA法检测抗CCP抗体、抗AMA及抗dsDNA抗体定量结果差异较大。AMA及ASMA的检测率不高。结论抗核抗体、抗dsDNA抗体、抗CCP抗体正确率较之前明显升高，三者准确率相似。抗ENA抗体的准确率较以往也略有提高。Objective To consecutively investigate the quality of auto-antibody testing of the whole country and to improve quality. Methods A nation-wide investigation was carried out and hospitals or departments participating were notified by letter or telephone communication. Autoantibodies tested for quality control survey included anti-nuclear antibody （anti-ANA）, anti-double-stranded DNA （anti-dsDNA）antibody, anti-extractable nuclear antigens （anti-ENA） antibody, anti-mitochondria antibody （AMA）, anti-smooth muscle antibody （ASMA） and anti-citrulline antibody （anti-CCP）. There were 15 samples in total for testing, including 3 control samples for each test. Same sample was used for both AMA and ASMA test. Sample distribution and data analysis were carried out double-blindly. A total of 114 hospitals or departments participated in the survey. Multiple testing methods were adopted including indirect immumo-fluo-rescence （IIF）, immuno-blot （IB）, dot-blot （DB）, double immuno-diffusion （DID）, enzyme linked immuno-sorbent assay （ELISA）, chemiluminescent assay, dot-immunogold filtration assay. Results The accurate rates for this survey were 98%, 96.6%, 89.5%, 98.1%, 92.1%, 96.4% respectively for ANA, anti-dsDNA, anti-ENA, AMA, ASMA and anti-CCP. Anti-ENAs were further divided into anti-RNP, anti-Sm, anti-SSA, anti-SSB and anti-Scl-70 subgroups, and the accurate rates were 88.4%, 96.8%, 100%, 100% and 95.8%, respectively. Titers of ANA varied greatly among different labs, so did quantitative analysis of anti-CCP, AMA and antidsDNA by ELISA. However, the accuracy of ANA types determined by IIF was greatly improved. Detection rate of AMA and AMSA was still low. Conclusion Among detected antibodies, ANA, anti-dsDNA and anti- CCP are the most prominently improved. Accurate rate of anti-ENA antibody is slightly increased.

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]