ICERA Consulting Ltd, Swindon, UK.
Thermo Fisher Scientific, Phadia AB, Uppsala, Sweden.
Autoimmun Rev. 2021 Nov;20(11):102943. doi: 10.1016/j.autrev.2021.102943. Epub 2021 Sep 9.
The objective of this meta-analysis was to review the diagnostic performance of anti-dsDNA testing, to determine whether test specificity meets the revised 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE). The new criteria state that anti-dsDNA testing should be conducted using "an immunoassay with demonstrated ≥ 90% specificity for SLE against relevant disease controls".
A systematic review (MEDLINE, Embase, CENTRAL and DARE) identified cross-sectional or case-control studies published January 2004 to August 2019, reporting anti-dsDNA test accuracy data. Studies included cases of SLE (confirmed using one or more of three validated SLE classification criteria sets) and a disease control group. Data were adjusted to exclude healthy controls. A hierarchical, bivariate mixed-effect meta-analysis of eligible quantitative studies was conducted in STATA MP v16.1 to produce a pooled estimate of sensitivity and specificity.
The review identified six fluorescence immunoassay (FEIA) dsDNA studies (1977 total patients, of whom 47% had SLE) eligible to be included in quantitative meta-analysis and all reported a point estimate >90% for specificity. The meta-analysis estimated a pooled specificity of 94.7% (95% CI 91.67%-96.67%).
The meta-analysis has demonstrated that the specificity of FEIA dsDNA is ≥90% for SLE, against relevant disease controls, and therefore performs in accordance with the 2019 classification criteria.
本荟萃分析旨在评估抗 dsDNA 检测的诊断性能，以确定其检测特异性是否符合 2019 年修订的欧洲抗风湿病联盟（EULAR）/美国风湿病学会（ACR）系统性红斑狼疮（SLE）分类标准。新标准指出，抗 dsDNA 检测应使用“针对相关疾病对照具有≥90%特异性的免疫测定法”进行。
通过系统检索（MEDLINE、Embase、CENTRAL 和 DARE），检索了 2004 年 1 月至 2019 年 8 月发表的横断面或病例对照研究，报告了抗 dsDNA 检测准确性数据。研究纳入了 SLE 病例（通过一种或多种三种经过验证的 SLE 分类标准集确诊）和疾病对照组。数据经过调整以排除健康对照者。使用 STATA MP v16.1 对符合条件的定量研究进行分层双变量混合效应荟萃分析，以得出敏感性和特异性的汇总估计值。
该综述确定了六项荧光免疫测定法（FEIA）dsDNA 研究（共纳入 1977 例患者，其中 47%为 SLE 患者），符合定量荟萃分析的纳入标准，所有研究均报告了特异性的点估计值>90%。荟萃分析估计 FEIA dsDNA 的特异性为 94.7%（95%CI 91.67%-96.67%）。
荟萃分析表明，FEIA dsDNA 对 SLE 的特异性≥90%，与相关疾病对照相比，其符合 2019 年分类标准。
