抗环瓜氨酸肽抗体IgG检测试剂(酶联免疫吸附试验)的临床试验  

Clinical test of anti-cyclic citrulline peptide(CCP)antibody IgG detection kit(ELISA)

作　　者：王思英 杨湘越 WANG Siying;YANG Xiangyue(Department of Blood Transfusion,the First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian 350005,China;Department of Clinical Laboratory,900th Hospital of Joint Logistics,Fuzhou,Fujian 350001,China)

机构地区：[1]福建医科大学附属第一医院输血科,福建福州350005 [2]中国人民解放军联勤保障部队第九〇〇医院检验科,福建福州350001

出　　处：《检验医学与临床》2022年第5期606-610,共5页Laboratory Medicine and Clinic

基　　金：福建省科技计划项目(2018Y0068)。

摘　　要：目的对欧蒙(杭州)医学实验诊断有限公司生产的酶联免疫吸附试验(ELISA)二类体外诊断试剂中抗环瓜氨酸肽(CCP)抗体IgG检测试剂进行临床验证试验,以评价该试剂的临床应用性能。方法收集中国人民解放军联勤保障部队第九〇〇医院67例类风湿关节炎患者有效血清标本及15例有效同源血浆标本为疾病组,19例其他关节炎等疾病患者有效血清标本及8例有效同源血浆标本为易混组,表观健康人血清标本30例、血浆标本30例为对照组。使用欧蒙(杭州)医学实验诊断有限公司拟注册的抗CCP抗体IgG检测试剂(ELISA)分别与上海荣盛生物药业有限公司(对照试剂)及欧蒙(德国)医学实验诊断有限公司(第三方试剂)生产的抗CCP抗体IgG检测试剂(ELISA)检测抗CCP抗体,通过计算符合率、Kappa值及回归分析拟注册试剂与其他2种试剂的一致性及相关性。结果待评价试剂与对照试剂的血清定性检测结果总符合率为88.79%,kappa值为0.69。对20份定量血清标本结果进行回归分析,回归方程为Y=1.629 X+0.9689,R=0.51。待评价试剂与第三方试剂的血清检测结果总符合率为92.24%,kappa值为0.80。针对26份定量结果进行分析,回归方程Y=0.9485 X-4.6402,R=0.97。待评价试剂与对照试剂检测不相符的标本,以第三方试剂的而检测结果为准,最终血清检测总符合率为97.41%,kappa值为0.93。待评价试剂检测血清与同源血浆检测总符合率为92.45%,kappa值为0.77。针对10份定量结果进行分析,回归方程:Y=0.835 X+15.886,R=0.92。结论待评价试剂经过临床试验验证,与对照试剂/第三方试剂血清及同源血浆检测结果一致性及相关性良好,具备应用性能。Objective Anti-cyclic citrullinated peptide(CCP)antibody IgG detection kit in an enzyme-linked immunosorbent assay(ELISA)typeⅡin vitro diagnostic kit produced by Oumeng(Hangzhou)Medical Experimental Diagnostic Co.,Ltd.was used for clinical verification tests to evaluate the clinical application performance of the kit.Methods The effective serum sample of 67 patients with rheumatoid arthritis and 15 effective homologous plasma sample in 900th Hospital of Joint Logistics were collected as the disease group,the effective serum sample of 19 patients with other other diseases such as arthritis and the 8 effective homologous plasma sample were susceptible to the mixed group.30 cases of serum sample and 30 cases of plasma sample were used as the control group.The anti-CCP antibody IgG detection(ELISA)kit to be registered by Oumeng(Hangzhou)Medical Laboratory Diagnosis Co.,Ltd.,Shanghai Rongsheng Biopharmaceutical Co.,Ltd.(the comparison reagent)and EUROIMMUN Medizinische Labordiagnostika AG(the tripartite reagent)were used to detect anti-CCP antibody,and the consistency and correlation between the proposed registration kit and the other two reagent were analyzed by calculating the coincidence rate,Kappa value and regression analysis.Results The total coincidence rate of the qualitative test results of the kit to be evaluated and the comparison reagent was 88.79%,and the kappa value was 0.69.Regression analysis on the results of 20 quantitative serum samples showed a regression equation of Y=1.629 X+0.9689,R=0.51.The total coincidence rate of serum test results of the kit to be evaluated and the tripartite reagent was 92.24%,and the kappa value was 0.80.Regression analysis on the results of 26 quantitative serum samples showed a regression equation of Y=0.9485 X-4.6402,R=0.97.For samples that do not match the evaluation kit and the comparison reagent,the test results of the tripartite reagents shall prevail.The final serum test compliance rate was 97.41%,and the kappa value was 0.93.The total coincidence rate of the se

关 键 词：抗环瓜氨酸肽抗体 临床试验 一致性 相关性 

分 类 号：R446.6[医药卫生—诊断学]