三种抗环瓜丝氨酸抗体检测试剂性能评价及临床应用

The analytical performance evaluation and clinical application of three assays for the measurement of anticyclic citrullinated peptide antibodies

目的评价3种抗环瓜丝氨酸(CCP)抗体检测试剂盒的分析性能,并比较临床应用。方法收集93例类风湿性关节炎(RA)患者、118例非RA疾病(自身免疫性疾病82例、骨关节炎36例)患者以及20名表面健康人群的血清样本,评价罗氏、欧蒙、富纯3种抗CCP抗体试剂的分析性能,比较不同试剂间的相关性,评估各自的初步临床应用价值。结果 3种试剂检测精密度差异无统计学意义,批内、天间变异系数(CV)均<10%。罗氏和欧蒙2种试剂在检测范围内呈线性,富纯试剂的真实线性范围为25.0～1 027.9 RU/mL。3种试剂检测结果相关性较好,罗氏与欧蒙、富纯试剂的相关系数(r)分别为0.90、0.87,欧蒙、富纯试剂的相关系数(r)为0.97。根据厂商提供的Cut-off值,诊断灵敏度可达83.9%～86.0%,特异性为92.0%～97.1%。罗氏、欧蒙、富纯检测试剂的受试者工作特征(ROC)曲线下面积(AUC)分别为0.91、0.92和0.89,比较任意2种检测试剂的AUC,差异均无统计学意义(Z值分别为0.27、0.89、0.63,P均>0.05)。结论总体来说,不同方法抗CCP抗体检测试剂的检测结果之间具有一定的可比性,临床应用的诊断特性差异不明显,但标准化仍存在问题。

Objective To evaluate the analytical performance of 3 assays for the measurement of anti-cyclic citrullinated peptide （CCP） antibodies, and compare the clinical application. Methods Serum samples from 93 patients with rheumatoid arthritis（ RA）, 118 non-RA patients （82 patients with autoimmune diseases and 36 patients with osteo arthritis ） and 20 healthy subjects were collected. The analytical performance of 3 reagents from Elecsys, Euroimmun and Fuchun was compared. The correlation was compared among the different reagents. The preliminary clinical application value for different reagents was evaluated. Results No statistical significance was found in precision of the 3 reagents. The within-run and interday coefficients of variation （CV） were 〈 10 %. Both of Elecsys and Euroimmun could be evaluated as linearity in detection range, and the real linearity range of Fuchun was 25. 0-1 027. 9 RU/mL. The correlation of anti-CCP assays by the 3 reagents was good. The correlations （r） of Elecsys with Euroimmun and Elecsys with Fuchun were 0.90 and 0.87 respectively, and the r of Euroimmun with Fuchun was 0.97. According to the cut-off values proposed by the manufacturers, the diagnostic sensitivities were 83.9 % - 86.0 %, and the specificities were 92.0 % - 97.1%. The areas under receiver operating characteristic （ROC） curve（AUC） of the anti-CCP assays by Elecsys, Euroimmun and Fuchun were 0.91, 0.92 and 0.89, respectively. There was no statistical difference between the AUC of any 2 assays（Z - 0.27, 0.89 and 0.63,P 〉 0.05）. Conclusions Overall, the analytical performance of anti-CCP assays is comparable among the different assays, and their diagnostic characteristics are not significantly different. However, the standardization still has problems.