全国180家实验室检测抗环瓜氨酸肽抗体的比对分析

Multi-center Comparison of Anti-cyclic Citrullinated Peptide Antibodies in 180 Laboratories of China

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 survey the current situations of anti-cyclic citrullinated peptide（CCP） antibody testing level in China and to improve the accuracy of analysis. Methods Five liquid serum samples with different concentrations were prepared by the Health Public Welfare Project research （project team ）, and then were uniformly sent to 180 laboratories. The study requests each lab. to finish testing within the set time, and the results were uploaded to website. Comparison and evaluation was finished by the project team. Results Sample CCP-1,CCP-3 ,and CCP-5 were the anti-CCP antibody positive,the coincident rate was 99.4% ,98.3% and 98.9% ,respectively. Sample CCP-2 and CCP-4 were anti-CCP antibody negative, the coincident rate was 98.9%. Enzyme-linked immunosorbent assay（ELISA）was the main method for the detection of anti-CCP antibody, and results among the ELISA kits of different manufacturers showed great volatile. Conclusion The coincident rates of comparisons of anti-CCP antibody in all labs are more than 98%, but the standardization of anti-CCP antibody testing remains to be improved.