Department of Rheumatology, Renji Hospital South Campus, Shanghai Jiao Tong University School of Medicine, 2000 Jiangyue Road, Shanghai, People's Republic of China.
Department of Diagnostic Reagents, Ningbo LANSEN Pharmaceutical Co., Ltd., Ningbo, Zhejiang, People's Republic of China.
Clin Rheumatol. 2018 Jan;37(1):139-144. doi: 10.1007/s10067-017-3771-x. Epub 2017 Jul 25.
To compare the performance of different commercial anti-dsDNA autoantibody assays, including multiplex-based immunoassay (Bio-Plex), Farr radioimmunoassay (Farr), ELISA, chemiluminescent immunoassay (CLIA), and Crithidia Luciliae indirect immunofluorescence test (CLIFT) in Chinese patients with systemic lupus erythematosus (SLE). SLE patients (n = 119) as well as healthy controls (n = 200) and disease controls (n = 100) were recruited, and serum anti-dsDNA autoantibodies were detected by Bio-Plex, Farr, two ELISA assays (Medical & Biological Laboratories-ELISA, EUROIMMU-ELISA), CLIA, and a standard CLIFT. The correlation of anti-dsDNA autoantibody levels to SLE disease activity was calculated, and the specificity and sensitivity of these methods were measured by receiver-operator characteristic (ROC) curve analysis. In ROC curve analysis, Bio-Plex showed the largest area under the curve (AUC) over other assays. Cutoff adjustment according to ROC enhanced the performance of all quantitative assays. Overall, Bio-Plex and CLIFT have higher specificity (>90.00%). ELISA and CLIA results are correlated with disease activity, and Bio-Plex results have the strongest correlation with SLEDAI score and active renal involvement. Bio-Plex assay has better overall performance in anti-dsDNA detection over Farr, ELISA, and CLIA methods in Chinese SLE patients.
为了比较不同商业抗 dsDNA 自身抗体检测方法的性能，包括基于多重免疫测定（Bio-Plex）、Farr 放射免疫测定（Farr）、ELISA、化学发光免疫测定（CLIA）和克氏锥虫间接免疫荧光试验（CLIFT）在中国系统性红斑狼疮（SLE）患者中的应用。招募了 119 例 SLE 患者、200 例健康对照者和 100 例疾病对照者，通过 Bio-Plex、Farr、两种 ELISA 检测试剂盒（Medical & Biological Laboratories-ELISA、EUROIMMU-ELISA）、CLIA 和标准 CLIFT 检测血清抗 dsDNA 自身抗体。计算了抗 dsDNA 自身抗体水平与 SLE 疾病活动度的相关性，并通过接收者操作特征（ROC）曲线分析测量了这些方法的特异性和敏感性。在 ROC 曲线分析中，Bio-Plex 显示出比其他检测方法更大的曲线下面积（AUC）。根据 ROC 进行的截断值调整增强了所有定量检测的性能。总体而言，Bio-Plex 和 CLIFT 的特异性较高（>90.00%）。ELISA 和 CLIA 结果与疾病活动度相关，而 Bio-Plex 结果与 SLEDAI 评分和活跃性肾受累相关性最强。在检测中国 SLE 患者的抗 dsDNA 方面，Bio-Plex 检测法在性能上优于 Farr、ELISA 和 CLIA 方法。
