参加美国病理家学会抗磷脂抗体能力验证活动效果分析

Analysis of the antiphospholipid antibodies testing results from College of American Pathologists proficiency testing

目的汇总分析北京协和医院风湿免疫科实验室和全世界参加美国病理家学会(College of American Pathologists,CAP)抗磷脂抗体(antiphospholipid antibodies,a PLs)项目的能力验证(proficiency testing,PT)活动8年的效果,以不断提高监控实验室检测a PLs项目的能力和质量。方法采用回顾性分析研究。北京协和医院风湿免疫科实验室自2009年1月至2016年12月,每年以邮件方式接收2批,每批3份检测样本,在10 d内采用酶联免疫吸附试验(enzyme-linked immununosorbent assay,ELISA)完成抗心磷脂抗体(anticardiolipin,a CL)、抗β2糖蛋白1抗体(anti-β2-glycoprotein 1,aβ2GP1)检测,并将结果回报CAP。结果本实验室自2009年1月起至2016年12月止,参加CAP的a PLs项目PT活动16次,共96个检测结果,所有结果均为可接受,总PT成绩为100%。8年期间,全世界参加CAP的a PLs项目PT活动的实验室数量逐年增加,2009年第1次PT与2016年第2次PT相比,参加a CLIg G PT活动的实验室数量增长了24.55%,参加a CL-Ig M PT活动的实验室数量增长了24.53%,参加a CL-Ig A PT活动的实验室数量增长了20.13%,参加aβ2GP1-Ig G PT活动的实验室数量增长了179.73%,参加aβ2GP1-Ig M PT活动的实验室数量增长了197.01%,参加aβ2GP1-Ig A PT活动的实验室数量增长了151.16%。检测方法逐渐由单一的ELISA变为多种方法学,包括ELISA法、化学发光法、荧光酶免疫分析法和液态芯片技术。全世界的回报结果显示,高滴度阳性和阴性样本检测结果的一致性较好,均高于90%,而低、中等滴度阳性样本检测结果的一致性较差。结论本实验室的a PLs项目检测结果达到了CAP的能力验证质量要求。全世界越来越多的实验室重视参与a PLs项目的室间质量评价活动,但弱阳性、中等强度阳性的a PLs样本的检测质量仍有待提高。

Objective To analyze our antiphospholipid antibodies（a PLs） testing results from College of American Pathologists（CAP） proficiency testing（PT） from January 2009 to December 2016, in order to continuously improve the detection of a PLs items in the monitoring laboratory. Methods The retrospective analysis was used. From January 2009 to December 2016, the laboratory of Rheumatology of Peking Union Medical College Hospital received 2 batches of 3 samples per year through mail, Enzyme linked immunosorbent assay（ELISA） was used to detect anticardiolipin（a CL） and anti-β2-glycoprotein 1（aβ2 GP1） within 10 days and the results were reported to CAP for evaluating. Results The laboratory took part in the CAP a PLs project PT activities for 16 times and obtained a total of 96 results. All the results were acceptable and the total PT score was 100%. The number of participates increased annually. Compared with the first PT in 2009, the number of laboratories participating in a CL-Ig G PT, a CL-Ig M PT a CL-Ig A PT, aβ2 GP1-Ig G PT, aβ2 GP1-Ig M PT and aβ2 GP1-Ig A PT increased by 24.55%, 24.53%, 20.13%,179.73%, 197.01% and 151.16% respectively in 2016. The detection method has gradually changed from a single ELISA method into a variety of methodologies, including ELISA, chemiluminescent immunoassay（CLIA）, fluorescence enzyme immunoassay（FEIA） and liquid chip technology（x MAP Technology）. The world return results showed good consistencies（more than 90%） in both the high-titer positive results and negative results, but the consistencies of the test results of the low-and medium-titer positive samples were poor. Conclusions Our a PLs results reach CAP′s quality verification requirement. Although more and more laboratories around the world pay attention to the external quality assessment of the a PLs project, but the quality of the detection of a PLs samples with weak positive to medium intensity remains to be improved.