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 articlepeer-review

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 (US)
Article number102943
JournalAutoimmunity Reviews
DOIs
StateAccepted/In press - 2021

Keywords

  • dsDNA
  • Fluorescence enzyme immunoassay
  • meta-analysis
  • Systematic literature review
  • Systemic lupus erythematosus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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