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目的调查全国抗环瓜氨酸肽(CCP)抗体的检测现状,了解各实验室检测的准确性。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(以下称“项目组”)制备比对样品(液体血清),包括5支不同抗CCP抗体水平的样品。项目组向全国180家实验室统一寄送比对样品,并要求各实验室在规定时间内完成检测,项目组对各实验室上传的检测结果及检测方法进行比对分析和评价。结果对CCP-1、CCP-3和CCP-5为抗CCP抗体阳性的样本,比对品检测结果符合率分别为99.4%、98.3%和98.9%;对CCP-2和CCP-4为抗CCP抗体阴性的样本,比对品检测结果符合率均为98.9%。酶联免疫吸附试验(ELISA)是检测抗CCP抗体的主要方法,不同厂家的ELISA试剂盒检测结果波动较大。结论 2013年全国实验室检测抗CCP抗体比对品的符合率较好,但检测仍亟需标准化。
Objective To investigate the detection status of anti-cyclic citrullinated peptide (CCP) antibody in the whole country and understand the accuracy of each laboratory test. Methods The comparative sample (liquid serum) was prepared by the public health industry scientific research project “Clinical application and promotion of key technologies of rheumatology disease diagnosis and treatment” project team (hereinafter referred to as the “project team”), including 5 different anti- Antibody level samples. The project team sent unified samples to 180 laboratories across the country and required the laboratories to complete the tests within the prescribed time. The project team conducted comparative analysis and evaluation on the test results and test methods uploaded by various laboratories. Results The coincidence rates of CCP-1, CCP-3 and CCP-5 which were positive for anti-CCP were 99.4%, 98.3% and 98.9%, respectively, and those of CCP-2 and CCP- Antibody negative samples, compared with the test results were 98.9%. Enzyme-linked immunosorbent assay (ELISA) is the main method for the detection of anti-CCP antibodies. The results of different ELISA kits from different manufacturers fluctuate greatly. Conclusion In 2013, the coincidence rate of laboratory-tested anti-CCP antibodies in China is better than that of the counterparts, but the testing is still in urgent need of standardization.