Specificity of anti-dsDNA Immunoassays in Systemic Lupus Erythematosus

Close up picture of microscope in the laboratory
The specificity of fluorescence immunoassays for anti–dsDNA was ≥90% in this meta-analysis of studies including patients with SLE.

The specificity of fluorescence immunoassay (FEIA) antidouble-stranded deoxyribonucleic acid (dsDNA) is at least 90% in patients with systemic lupus erythematosus (SLE), according to a meta-analysis published in Autoimmunity Reviews.

The researchers conducted a meta-analysis to evaluate the diagnostic performance of anti-dsDNA testing, in order to establish whether test specificity fulfilled the revised 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for SLE. The new criteria indicate that anti-dsDNA testing should be conducted using “an immunoassay with demonstrated at least 90% specificity for SLE against relevant disease controls.”

The systematic review identified case-control or cross-sectional studies published between January 2004 and August 2019 in which anti-dsDNA test accuracy data were reported. All of the studies included cases of SLE that were confirmed with the use of at least 1 of 3 validated SLE classification criteria sets and a disease control group. 

Data were adjusted such that healthy patients serving as control participants were excluded from the analysis.

A hierarchical, bivariate, mixed-effect model was used to carry out the meta-analysis in STATA MP 16.1.

Overall, 6 dsDNA studies were identified that included a total of 1977 patients — 47% of whom had SLE and were eligible for inclusion in the quantitative meta-analysis. All 6 of these studies reported a point estimate of more than 90% with respect to specificity. A pooled specificity of 94.7% was estimated in the meta-analysis (95% CI, 91.67%-96.67%).

The investigators concluded that the results of the current meta-analysis demonstrated that the FEIA dsDNA performed in accordance with the revised 2019 EULAR/ACR classification criteria.

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 


Orme ME, Voreck A, Aksouh R, Ramsey-Goldman R, Schreurs MWJ. Systematic review of anti-dsDNA testing for systemic lupus erythematosus: A meta-analysis of the diagnostic test specificity of an anti-dsDNA fluorescence enzyme immunoassay. Autoimmun Rev. 2021;20(11):102943. doi:10.1016/j.autrev.2021.102943