Department of Clinical Laboratory, The First People's Hospital of Wenling, Affiliated to Wenzhou Medical University, Taizhou, China.
Department of Rheumatology, The First People's Hospital of Wenling, Affiliated to Wenzhou Medical University, Taizhou, China.
Front Immunol. 2022 Aug 2;13:940713. doi: 10.3389/fimmu.2022.940713. eCollection 2022.
To evaluate a novel fully automated immunoturbidimetric assay developed by Qiangsheng Biotechnology Company for the detection of anticyclic citrullinated peptide antibodies (anti-CCP) in serum of patients with rheumatoid arthritis (RA) and compare it to the conventional EUROIMMUN- anti-CCP ELISA. Two other commonly used automated assays, the Elecsys anti-CCP assay, an ECLIA that is run on the Modular Analystics E170 (Cobas Diagnostics, Germany), and an anti-CCP CLIA developed by YHLO that is run on the iFlash 3000 Chemiluminescence Immunoassay Analyzer, were included as reference standards.
A total of 264 serum samples were collected from patients attending the First People's Hospital of Wenling affiliated to Wenzhou Medical University between July 2020 and November 2020. These included 131 serum samples collected from patients with RA, 70 serum samples collected from patients with other autoimmune diseases, and 63 serum samples collected from healthy controls at a physical examination. The clinical performance and sensitivity and specificity of the four anti-CCP assays for the diagnosis of RA were compared using receiver operating characteristic (ROC) curve analysis.
The Kappa statistic indicated almost perfect agreement between the EUROIMMUN-anti-CCP ELISA and the Elecsys anti-CCP ECLIA (Cobas) (0.863), the EUROIMMUN-anti-CCP ELISA and the anti-CCP CLIA (YHLO) (0.862), and the Elecsys anti-CCP ECLIA (Cobas) and the anti-CCP CLIA (YHLO) (0.816). On ROC curve analysis, AUC values were 0.955 for the EUROIMMUN-anti-CCP ELISA, 0.948 for the anti-CCP CLIA (YHLO), 0.947 for the Elecsys anti-CCP ECLIA (Cobas) and 0.903 for Qiangsheng, indicating all the assays had a good diagnostic performance for RA.
The anti-CCP assays provided similar diagnostic information. The novel fully automated immunoturbidimetric assay for anti-CCP developed by Qiangsheng Biotechnology Company may be especially useful for large scale clinical screening in RA as it has a shorter testing time than the commercially available alternatives.
评估强圣生物技术公司开发的新型全自动免疫比浊法检测类风湿关节炎（RA）患者血清中环瓜氨酸肽抗体（抗-CCP）的效果，并与常规 EUROIMMUN-抗-CCP ELISA 进行比较。还纳入了两种常用的自动化检测方法，即电化学发光免疫分析法（ECLIA）检测的 Elecsys 抗-CCP 检测法（罗氏诊断公司，德国）和医华生物科技有限公司开发的基于 iFlash 3000 化学发光免疫分析仪的抗-CCP CLIA 作为参考标准。
共收集了 2020 年 7 月至 2020 年 11 月期间在温州医科大学附属温岭第一人民医院就诊的患者的 264 份血清样本。这些样本包括 131 份来自 RA 患者的血清样本、70 份来自其他自身免疫性疾病患者的血清样本和 63 份来自体检健康对照者的血清样本。使用受试者工作特征（ROC）曲线分析比较四种抗-CCP 检测方法在 RA 诊断中的临床性能和敏感性及特异性。
kappa 统计分析显示，EUROIMMUN-抗-CCP ELISA 与 Elecsys 抗-CCP ECLIA（罗氏）（0.863）、EUROIMMUN-抗-CCP ELISA 与抗-CCP CLIA（医华）（0.862）、Elecsys 抗-CCP ECLIA（罗氏）与抗-CCP CLIA（医华）（0.816）之间的一致性几乎达到完美。ROC 曲线分析显示，EUROIMMUN-抗-CCP ELISA 的 AUC 值为 0.955，抗-CCP CLIA（医华）为 0.948，Elecsys 抗-CCP ECLIA（罗氏）为 0.947，强圣为 0.903，表明所有检测方法对 RA 均具有良好的诊断性能。
四种抗-CCP 检测方法提供了相似的诊断信息。强圣生物技术公司开发的新型全自动免疫比浊法检测抗-CCP 可能特别适用于 RA 的大规模临床筛查，因为其检测时间比市售方法更短。
