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

• Published in: Autoimmunity reviews 2021-11, Vol.20 (11), p.102943, Article 102943
• Main Authors: Orme, Michelle E., Voreck, Anja, Aksouh, Redha, Ramsey-Goldman, Rosalind, Schreurs, Marco W.J.
• Format: Article
• Language: English
• Subjects: dsDNA; Fluorescence enzyme immunoassay; meta-analysis; Systematic literature review; Systemic lupus erythematosus
• ISSN: 1568-9972; 1568-9972
• DOI: 10.1016/j.autrev.2021.102943

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. •Testing of anti-dsDNA in SLE patients is crucial for disease classification and diagnosis.•The 2019 EULAR/ACR classification criteria for SLE state the use of “an immunoassay with demonstrated ≥ 90% specificity” for anti-dsDNA testing.•A FEIA dsDNA test demonstrates the required ≥90% specificity in accordance with the SLE classification criteria.