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

Michelle E. Orme*, Anja Voreck, Redha Aksouh, Rosalind Ramsey-Goldman, Marco W.J. Schreurs

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

2 Citations (Scopus)
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Abstract

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.

Original languageEnglish
Article number102943
JournalAutoimmunity Reviews
Volume20
Issue number11
Early online date9 Sep 2021
DOIs
Publication statusPublished - Nov 2021

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