Department of Oncology, Hematology, Rheumatology and Clinical Immunology, Clinic of Internal Medicine III, University Hospital of Bonn, Bonn, Germany.
Department of Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany.
Front Immunol. 2023 Dec 7;14:1305865. doi: 10.3389/fimmu.2023.1305865. eCollection 2023.
Elevated double-stranded DNA (dsDNA) antibody levels in blood serum are considered a disease-specific marker in systemic lupus erythematosus (SLE), correlate with disease activity and the incidence of lupus nephritis, and can be detected in up to 86% of all SLE cases. Despite the high clinical relevance, the variety of dsDNA antibody testing methods with heterogenous performance in clinical use remains challenging. This study is the first to prospectively investigate the performance of two of today's most commonly applied anti-dsDNA testing methods head-to-head under real-world conditions, as well as their correlation with other clinical and serological disease parameters in SLE patients.
In this prospective study, all SLE patients undergoing treatment at the Department of Rheumatology at the University Hospital Bonn within a 13-months period (n=41) and control patients without connective-tissue disease (n=51) were consecutively enrolled and examined. For all study participants' serum samples both anti-dsDNA-NcX enzyme-linked immunoassay testing EUROIMMUN, Luebeck, Germany) and the fluorescence immunoassay ELiA dsDNA (Thermo Fisher Scientific, Waltham, USA) were performed. In addition, demographic data, further laboratory values and disease activity parameters were recorded. Clinical disease activity was assessed by SLEDAI-2K.
Both assays showed high specificity (anti-dsDNA-NcX ELISA: 0.9, ELiA dsDNA: 0.959), but there were notable differences in sensitivity (anti-dsDNA-NcX ELISA: 0.51, ELiA dsDNA: 0.38). Pearsons's correlation yielded a positive correlation between anti-dsDNA concentrations and CRP concentrations for the anti-dsDNA-NcX ELISA (R=0.22; p=0.038) and a mild-to-moderate inverse correlation between concentrations of anti-dsDNA and complement C4 for the ELiA dsDNA test (R=-0.22; p=0.045) when SLE and control patients were considered together. Other than, no significant correlation between anti-dsDNA concentrations and clinical or laboratory findings was found for either test procedure.
Both anti-dsDNA antibody assays represent reliable examination methods with high specificity for the diagnosis of SLE that fulfill EULAR/ACR requirements. However, the anti-dsDNA-NcX ELISA showed superior sensitivity and significant correlation with disease activity (as measured by CRP concentrations).
血清中双链 DNA（dsDNA）抗体水平升高被认为是系统性红斑狼疮（SLE）的特异性疾病标志物，与疾病活动度和狼疮肾炎的发生率相关，在多达 86%的所有 SLE 病例中均可检测到。尽管具有很高的临床相关性，但由于不同的 dsDNA 抗体检测方法在临床应用中具有不同的性能，因此仍然具有挑战性。本研究首次前瞻性地比较了两种当今最常用的抗 dsDNA 检测方法在实际条件下的性能，并比较了它们与 SLE 患者其他临床和血清学疾病参数的相关性。
在这项前瞻性研究中，连续纳入并检查了在波恩大学医院风湿病科接受治疗的所有 SLE 患者（n=41）和无结缔组织疾病的对照组患者（n=51）。对所有研究参与者的血清样本，均进行抗 dsDNA-NcX 酶联免疫吸附试验（EUROIMMUN，吕贝克，德国）和荧光免疫分析 ELiA dsDNA（赛默飞世尔科技，沃尔瑟姆，美国）检测。此外，还记录了人口统计学数据、其他实验室值和疾病活动参数。SLEDAI-2K 评估临床疾病活动度。
两种检测方法均显示出高特异性（抗 dsDNA-NcX ELISA：0.9，ELiA dsDNA：0.959），但敏感性存在明显差异（抗 dsDNA-NcX ELISA：0.51，ELiA dsDNA：0.38）。Pearsons 相关分析显示，抗 dsDNA-NcX ELISA 中抗 dsDNA 浓度与 CRP 浓度之间存在正相关（R=0.22；p=0.038），ELiA dsDNA 试验中抗 dsDNA 浓度与补体 C4 之间存在轻度至中度负相关（R=-0.22；p=0.045）。此外，两种检测方法均未发现抗 dsDNA 浓度与临床或实验室发现之间存在显著相关性。
两种抗 dsDNA 抗体检测方法均为可靠的检测方法，具有较高的特异性，可用于 SLE 的诊断，符合 EULAR/ACR 的要求。然而，抗 dsDNA-NcX ELISA 的敏感性更高，与疾病活动度（以 CRP 浓度衡量）显著相关。
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