From the Guidelines
Double-stranded DNA (dsDNA) antibodies (anti-dsDNA AB) are a specific marker for systemic lupus erythematosus (SLE) and should be tested when SLE is suspected, particularly in patients presenting with symptoms such as joint pain, skin rashes, photosensitivity, oral ulcers, or renal abnormalities. The test is typically performed using enzyme-linked immunosorbent assay (ELISA), Crithidia luciliae immunofluorescence test (CLIFT), or radioimmunoassay methods 1. High titers of anti-dsDNA antibodies correlate with disease activity and are associated with lupus nephritis, making them valuable for both diagnosis and monitoring treatment response 1. False positives can occur in other autoimmune conditions, so results should be interpreted alongside clinical findings and other laboratory tests 1. Regular monitoring of anti-dsDNA levels can help guide treatment decisions and predict disease flares in patients with established SLE 1. Some key points to consider when testing for anti-dsDNA antibodies include:
- The use of a double-screening strategy using a last-generation SPA in the first place and, subsequently, the CLIFT as the confirmation test 1
- The importance of selecting the most adequate assay and an appropriate interpretation of results 1
- The need to incorporate alternative automated methods and to define nuclear and cytoplasmic staining 1
- The recommendation to monitor anti-dsDNA levels every 6-12 months in patients with no activity, no damage, and no comorbidity 1
- The use of quantitative determination of anti-dsDNA antibodies for monitoring SLE disease activity 1
From the FDA Drug Label
Treatment with BENLYSTA in adult patients led to reductions in IgG and anti-double-stranded DNA antibodies (anti-dsDNA) which were observed as early as Week 8 and sustained through Week 52.
- Reductions in anti-dsDNA antibodies were observed with belimumab treatment, as early as Week 8 and sustained through Week 52 2.
- This suggests that belimumab may be effective in reducing anti-dsDNA antibodies in patients with systemic lupus erythematosus (SLE) 2.
From the Research
Detection of Anti-dsDNA Antibodies
- The detection of anti-dsDNA antibodies is crucial in the diagnosis of systemic lupus erythematosus (SLE) 3, 4, 5.
- Several methods have been used to measure anti-dsDNA antibodies, including RIA, ELISA, CLIA, and Crithidia luciliae fluorescence test (CLIFT) 3, 4, 5.
- The combination of two quantitative methods, such as RIA and CLIA, and the ANA pattern is the most efficient strategy for detecting anti-dsDNA antibodies in SLE patients 3.
- The specificity and positive predictive value (PPV) of anti-dsDNA antibody tests increase with the number of assay methods used 3.
Clinical Significance of Anti-dsDNA Antibodies
- Anti-dsDNA antibodies are highly specific markers of SLE, but can also be found in other diseases, such as rheumatological disorders, infections, and malignancy 6.
- The level of anti-dsDNA antibodies can be associated with the severity of the disease, with higher levels often found in patients with more severe symptoms 6.
- The detection of anti-dsDNA antibodies can be used in combination with other tests, such as ANA screening, to improve the diagnosis of SLE 4, 7.
- The sensitivity and specificity of anti-dsDNA antibodies in the diagnosis of SLE can be high, especially when using control sera obtained from healthy individuals and patients with multiple medical problems 7.
Methods for Detecting Anti-dsDNA Antibodies
- ELISA is a commonly used method for detecting anti-dsDNA antibodies, but it may also yield positive results in conditions other than SLE, such as chronic liver diseases and infections 5.
- The Farr assay is a radioimmunological method that can detect anti-dsDNA antibodies with high specificity, but it may not detect antibodies of low avidity 5.
- CLIFT is a sensitive method for detecting anti-dsDNA antibodies, but it may require confirmation by other tests, such as the Farr assay or ELISA 4, 5.