2009年我国102家医院实验室自身抗体检测室间质量评价分析

Analyses of the external quality assessment of autoantibodies testing from 102 laboratories in 2009 in China

目的了解我国自身抗体检测现状，以改进和提高自身抗体检测质量。方法对2009年自愿报名参加自身抗体检测质量评价的102家实验室，于2009年10月发放日本MBL公司提供的抗核抗体（ANA）、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）抗体各3份质控品，共15份质控样本。各单位按各自的常规方法检测，并将检测项目的定性结果（ANA、抗dsDNA抗体、抗ENA抗体、AMA／ASMA、抗CCP抗体）、核型（ANA）、滴度（ANA、抗dsDNA抗体、AMA／ASMA）以及检测所用方法等结果填入统一表格寄回。该15份质控标本也同时向希腊、意大利、日本、韩国、葡萄牙及中国台湾等其他地区的实验室发放，回报结果由日本MBL公司进行统计分析，中国实验室回报结果的统计分析由本实验室完成。质控样本发放和结果分析均采用双盲操作，采用Excel软件对回报结果进行统计及描述性评价。因自身抗体检测的特殊性，仅对定性结果采用正确率（3份样本检测结果均正确回报的实验室数／参加该项目检测实验室总数）进行描述性评价，定量结果仅供参考。结果以日本MBL公司2009年在各国家及地区自身抗体检测评价的揭盲结果为评判依据，ANA、抗dsDNA抗体、AMA、ASMA、抗ENA抗体和抗CCP抗体质控样品的正确率分别为80．8％（80／99）、81．2％（78／96）、86．3％（44／s1）、76．3％（29／38）、95．9％（93／97）和93．1％（67／72）。间接免疫荧光法检测ANA滴度的正确率较低，901号样本为12．7％（11／79），902号样本为7．6％（6／79）。抗CCP抗体不同厂家试剂盒检测结果波动较大，921号和923号样本检测值的波动范围分别为10．0-419．0、15．3-418．5U／ml。结论2009年我国ANA、抗dsDNA抗体、AMA和ASMA检测的正确率均低于90％，而抗ENA抗体和抗CCP抗体检测的正确率令人满意（均〉90％）。ANA的核型与滴度、AMA和ASMA检测的室内质控以及抗CCP抗体检测的室间质控仍有待提高。r手华j绘验医学杂啬，2012，35：265-270）

Objective To evaluate and improve the quality of autoantibodies testing in China. Methods 102 laboratories participated voluntarily in the survey of the quality of autoantibodies testing in October 2009 and received a total of 15 samples from Japan MBL company including 5 different assays：antinuclear antibody （ANA）, anti-double strain DNA （dsDNA） antibody, anti-extractable nuclear antigen （ENA） antibody, anti-mitoehondrial antibody （AMA）, anti-smooth muscle antibody （ASMA） and anti-cyclic citrullinated peptide （CCP） antibodies. There were 3 samples for each assay. The samples were detected by routine methods. The results were reported with qualitive results （for all） , titer （for ANA, anti- dsDNA antibody and AMA/ASMA） , patterns （for ANA） and methods. At the same time, MBL company also distributed the samples to the laborotories in the other areas, Greece, Italy, Japan, Korea, Portugue and China Taiwan, respectively. The results from the other areas were analyzed by MBL company. The resuhs from China were analyzed in our laborotories. The distribution of samples and analysis of testing results was double-blinded. Descriptive analysis were performed with Excel. Only descriptive analysis of the qualitiveresult, positive rate （laboratories that all three results were right/ laboratories that took part in the relevant autoantibody detection） were done, and quantity results were set as reference. Results According to the standard results from the analysis of MBL company the rate of satisfied results of ANA, anti-dsDNA antibody, AMA, ASMA, anti-ENA antibody and anti-CCP were 80. 8% （80/99）, 81.2% （78/96）, 86. 3% （44/51）, 76.3% （29/38） ,95.9% （93/97） and 93.1% （67/72） , respectively. The accuracy rate of the titer for ANA was low and related results of sample 901 and 902 were 12. 7% （11/79） and 7.6% （6/ 79 ） , respectively. Also a considerable discrepancy was found in the results of anti-CCP among different laboratories using different commercial kits. The ranges of sample 921 and 923 were 10.0-419.0 U/ml and 15.3-418.5 U/rnl, respectively. Conclusions The accuracy rates of the rate of satisfied results among ANA, anti-dsDNA antibody, AMA, and ASMA were lower than 90% , however, it＇s satisfed that the rate is higher than 90% in anti-ENA antibody and anti-CCP. Internal quality control of ANA titer, AMA and ASMA, and external quality assurance of anti-CCP should be improved. （Chin J Lab Med, 2012,35：265- 270）