BioPlex^(TM)2200全自动免疫分析仪检测抗环瓜氨酸肽抗体的性能评估  

The analytical performance evaluation of BioPlex^(TM) 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies

作　　者：赵瀛[1] 黄斐[1] 宋斌斌[1] 郭玮[1] 潘柏申[1] 

机构地区：[1]上海复旦大学医学院附属中山医院检验科,上海200032

出　　处：《检验医学》2014年第2期153-157,共5页Laboratory Medicine

基　　金："十二五"国家科技支撑计划课题(2012BAI37B01);国家临床重点检验专科建设项目

摘　　要：目的评估BioPlexTM2200全自动免疫分析仪(简称BioPlexTM2200)检测抗环瓜氨酸肽(CCP)抗体的分析性能和临床应用价值。方法采用BioPlexTM2200检测65例类风湿关节炎(RA)患者、46例非RA患者(自身免疫疾病31例、骨关节炎15例)及20名表面健康者血清抗CCP抗体,评价其分析性能和初步临床应用价值,并与Roche检测系统进行一致性比较。结果高、中、低浓度混合血清的批内精密度分别为2.4%、3.3%、4.4%;天间精密度分别为4.5%、3.5%、5.6%。经多项式回归分析,BioPlexTM2200在0.5~294.6 U/mL范围内呈线性。BioPlexTM2200与Roche检测系统结果的一致性较好(kappa值为0.873)。受试者工作特征(ROC)曲线显示抗CCP抗体诊断RA的最佳诊断Cut-off值为2.3 U/mL,诊断灵敏度和特异性分别为80.0%和98.5%。结论BioPlexTM2200检测抗CCP抗体的分析性能较好,能够适用于临床对于RA的诊断和疗效评估。Objective To evaluate the analytical performance of BioPlexTM 2200 automatic immunoassay analyzer （Bio PlexTM 2200）for the determination of anti-cyclic citrullinated peptide （CCP）antibodies,and assess its clinical application significance.Methods Serum samples from 65 patients with rheumatoid arthritis （RA ）,46 non-RA patients（31 patients with various autoimmune diseases and 1 5 patients with osteoarthritis）and 20 healthy subjects were collected.Their anti-CCP antibodies were determined by Bio PlexTM 2200.The analytical performance and preliminary clinical application significance of BioPlexTM 2200 were evaluated.The consistency was evaluated between BioPlexTM 2200 and Roche Elecsys assay. Results The within-run and inter-day precisions of high, moderate and low concentrations of sera were 2.4% /4.5%,3.3% /3.5% and 4.4%/5.6%,respectively.BioPlexTM 2200 could be evaluated as liner in the range of 0.5-294.6 U/mL through polynomial regression analysis.The consistency between BioPlexTM 2200 and Roche Elecsys assay was good （kappa value was 0.873）.The optimal cut-off value for the diagnosis of anti-CCP antibodies was 2.3 U/mL by receiver operating characteristic （ROC）curve,the diagnostic sensitivity was 80.0%,and the diagnostic specificity was 98.5%.Conclusions BioPlexTM 2200 has a good analytical performance, and it can be applied to the clinical diagnosis of RA and the monitoring of treatment efficacy.

关 键 词：抗环瓜氨酸肽抗体 类风湿关节炎 精密度 线性 受试者工作特征曲线 

分 类 号：R446.1[医药卫生—诊断学]