2013年全国116家实验室抗磷脂抗体检测比对分析

Comparison Analyses of the Detection of Anti-phospholipid Antibodies in 116 Laboratories across the Country in 2013

目的了解全国抗磷脂抗体检测水平现状,发现问题,以改进和提高检测质量。方法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＂项目组制备比对样品（液体血清）,向全国自愿报名参加抗磷脂抗体检测的实验室发放比对样品。比对样品包括抗心磷脂抗体（anti-cardiolipin antibodies,ACL）和抗β2糖蛋白I（anti-β2-glycoprotein I,β2GPI）抗体,1组共5支血清,由项目组统一寄送至各实验室。要求各实验室在规定时间内完成检测,并将结果上传至项目组。采用Excel软件对检测结果进行描述性评价及统计分析。结果全国参加APLs比对分析的实验室共116家,进行ACL抗体和抗β2GPI抗体检测实验室分别为107家和63家。样品201、203及204为ACL抗体和抗β2GPI抗体双阳性,样品202和205为双阴性。比对品ACL抗体及抗β2GPI抗体检测结果阳性符合率分别为96.6%和98.4%,阴性符合率分别为99.5%和100%。酶联免疫吸附试验是检测ACL抗体、抗β2GPI抗体的主要方法,不同厂家的ELISA试剂盒检测结果有一定波动（变异系数为31.0%-90.0%）。结论 2013年全国实验室抗磷脂抗体比对品检测正确率高于96%,但抗磷脂抗体检测结果的标准化、统一化还需进一步提高。

Objective To study the current situations anti-phospholipid antibodies in China, identifying the issues in order to improve and enhance its detection quality. Methods Preparation by the Health Public Welfare Project research ＂rheumatic autoimmune disease diagnosis and treatment＇s key clinical technology promotion and transformation applied research ＂（ here in after referred to as the ＂project team ＂）, the samples（ liquid serum） were given out to the 116 laboratories which were volunteered to participate in antiphospholipid antibodies testing project. Comparison samples include anti-cardiolipin antibodies（ ACL）,anti-β2-glycoprotein I（ β2GPI） antibodies and 1 set of 5 bottles of serum. These samples were sent to eachlab by the project team uniformly. The experiment requests each lab to finish testing within the set time,and the results will be uploaded to website. This thesis adopts the Excel to carry on descriptive evaluation and statistical analysis for the test results. Results A total of 116 laboratories took part in the comparative analysis for APLs all over the country. There are each 107 and 63 testing laboratories to participate in the ACL and anti-β2-GPI antibodies. ACL and anti-β2-GPI antibodies in samples of 201,203,and 204 show positive,otherwise the samples of 202 and 205 are double negative. Comparing the testing results of ACL and anti-β2-GPI antibodies,the positive rates were 96. 6% and 98. 4%,on the contrary,the negative rates was 99. 5% and 100%. Enzyme-linked immunosorbent assay（ ELISA） is the main method of detection for anti-cardiolipin antibodies and anti-β2-glycoprotein I antibodies,and results among the ELISA kits of different manufacturers showed great volatile（ CV 31. 0%-90. 0%）. Conclusion In 2013,the accuracy rates of comparisons of anti-phospholipid antibodies in all labs are higher than 96%. But the standardization and unification of anti-phospholipid antibodies testing results remains to be improved.