BioPlexTM 2200全自动免疫分析仪检测抗环瓜氨酸肽抗体的性能评估

doi:10.3969/j.issn.1673-8640.2014.02.015

检验医学 ›› 2014, Vol. 29 ›› Issue (2): 153-157.DOI: 10.3969/j.issn.1673-8640.2014.02.015

• 技术研究与评价·论著 • 上一篇下一篇

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

赵瀛, 黄斐, 宋斌斌, 郭玮, 潘柏申

上海复旦大学医学院附属中山医院检验科, 上海 200032

收稿日期:2013-01-28 出版日期:2014-02-20 发布日期:2014-02-20
通讯作者: 潘柏申, 联系电话:021-64041990-2376
作者简介:赵瀛, 女, 1980年生, 学士, 主管技师, 主要从事临床免疫工作。
基金资助:
“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

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

ZHAO Ying, HUANG Fei, SONG Binbin, GUO Wei, PAN Baishen.

Department of Clinical Laboratory, Zhongshan Hospital, Fudan University School of Medicine, Shanghai 200032, China

Received:2013-01-28 Online:2014-02-20 Published:2014-02-20

摘要/Abstract

摘要：

目的评估BioPlex^TM 2200全自动免疫分析仪(简称BioPlex^TM 2200)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BioPlex^TM 2200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, BioPlex^TM 2200在0.5～294.6 U/mL范围内呈线性。BioPlex^TM 2200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 BioPlex^TM 2200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。

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

Abstract:

Objective To evaluate the analytical performance of BioPlex^TM 2200 automatic immunoassay analyzer (Bio Plex^TM 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 15 patients with osteoarthritis)and 20 healthy subjects were collected. Their anti-CCP antibodies were determined by Bio Plex^TM 2200.The analytical performance and preliminary clinical application significance of BioPlex^TM 2200 were evaluated. The consistency was evaluated between BioPlex^TM 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. BioPlex^TM 2200 could be evaluated as liner in the range of 0.5-294.6 U/mL through polynomial regression analysis. The consistency between BioPlex^TM 2200 and Roche Elecsys assay was good (kappa value was 0.873). The optimal cut-off valuefor 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 BioPlex^TM 2200 has a good analytical performance, and it can be applied to the clinical diagnosis of RA and the monitoring of treatment efficacy.

Key words: Anti-cyclic citrullinated peptide antibody, Rheumatoid arthritis, Precision, Linearity, Receiver operating characteristic curve

中图分类号:

R446.1

赵瀛, 黄斐, 宋斌斌, 郭玮, 潘柏申. 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[J]. 检验医学, 2014, 29(2): 153-157.

ZHAO Ying, HUANG Fei, SONG Binbin, GUO Wei, PAN Baishen.. The analytical performance evaluation of BioPlex^TM 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies[J]. , 2014, 29(2): 153-157.

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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

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BioPlexTM 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 BioPlexTM 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies

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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