Anti-dsDNA Testing Specificity for Systemic Lupus Erythematosus: A Systematic Review

Area of Science:

• Immunology
• Clinical Chemistry
• Rheumatology

Background:

• Autoantibody specificity in autoimmune diseases is highly variable.
• Differences in detection methods and tests contribute to variability in autoantibody specificity.
• False-positive results in autoantibody testing can have significant downstream consequences for patient management.

Purpose of the Study:

• To conduct a comprehensive assessment of anti-double stranded DNA (anti-dsDNA) antibody specificity in systemic lupus erythematosus (SLE).
• To evaluate the specificity of various anti-dsDNA detection methods and tests used in SLE diagnosis.
• To provide guidance for laboratory specialists and clinicians in selecting and interpreting anti-dsDNA tests.

Main Methods:

• A systematic review of published studies (January 2004 to August 2019) was performed using multiple databases (MEDLINE, Embase, Cochrane).
• Cross-sectional or case-control studies reporting anti-dsDNA test accuracy data in SLE patients were included.
• A meta-analysis was conducted to estimate specificity by test method, with study quality assessed using the Quality Assessment Tool for Diagnostic Accuracy Studies (version 2).

Main Results:

• Thirty studies encompassing 43 different tests were analyzed.
• The Crithidia luciliae indirect immunofluorescence test (CLIFT) and fluorescence enzyme immunoassay methods demonstrated high specificity (≥90%).
• Specificity was not consistently demonstrated to be ≥90% for other methods, including NOVA Lite, chemiluminescence immunoassays, multiplex immunoassays, and Farr fluorescent immunoassays, with some lacking sufficient data or using potentially overestimating control groups.

Conclusions:

• Anti-dsDNA testing exhibits considerable variation in specificity, impacting SLE patient management.
• Certain methods, such as CLIFT and fluorescence enzyme immunoassays, show promising specificity.
• Further research is needed to clarify the specificity of other anti-dsDNA tests and guide optimal clinical use.