Journal
AUTOIMMUNITY REVIEWS
Volume 20, Issue 11, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.autrev.2021.102943
Keywords
dsDNA; Systemic lupus erythematosus; Fluorescence enzyme immunoassay; meta-analysis; Systematic literature review
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This meta-analysis reviewed the diagnostic performance of anti-dsDNA testing and found that the specificity of FEIA dsDNA is >90% for SLE, meeting the 2019 classification criteria.
Background and aims: 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. Materials and methods: 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. Results: 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%). Conclusion: 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.
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