TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: ADNA    
DNA Double-Stranded Antibodies, IgG, Serum

Useful For Suggests clinical disorders or settings where the test may be helpful

Evaluating patients with clinical features or at-risk for systemic lupus erythematosus (SLE)

 

An adjunct test for monitoring disease activity in SLE patients previously positive for double-stranded DNA IgG antibodies

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Of the systemic lupus erythematosus (SLE)-specific antibodies outlined in the immunology domain of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE,(1) antibodies to double-stranded DNA (dsDNA) is the most common. It is also included in the Systemic Lupus International Collaborating Clinics classification criteria (SLICC) for SLE.(2) Detection of IgG antibodies to dsDNA is the most used isotype clinically.(3-5) The diagnostic performance of dsDNA IgG antibodies in SLE is variable and dependent on several factors; notably the immunological method used for their detection, the structure of the DNA, the patient’s disease state (early or active vs inactive) including specific clinical manifestations and demographics.(3-7) Weak-positive dsDNA IgG antibodies have low affinity and low avidity with variable clinical correlations for SLE.(3)

 

Testing for IgG antibodies to dsDNA is indicated in patients positive for anti-cellular antibody (ie, antinuclear antibody: ANA) homogeneous pattern using HEp-2 substrate by indirect immunofluorescence assay (IFA) along with clinical features compatible with SLE.(1,2,8). A minority of SLE patients may test negative using HEp-2 by IFA for nuclear antibodies.(8,9) Testing antibodies associated with HEp-2 IFA cytoplasmic pattern such as ribosomal P IgG autoantibodies may be useful if features of neuropsychiatric disease are present. Alternatively, patients may be tested for Smith, ribonucleoprotein, SSA-52, and SSA-60 antibodies.(8,9)

 

The levels of antibodies to dsDNA may fluctuate with SLE disease activity. Increasing antibody levels may be associated with flares while decline or negative results may indicate response to treatment or disease remission.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<30.0 IU/mL (negative)

30.0-75.0 IU/mL (borderline)

>75.0 IU/mL (positive)

Negative is considered normal.

Reference values apply to all ages.

Interpretation Provides information to assist in interpretation of the test results

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Measurements of IgG antibodies to double-stranded DNA (dsDNA) are semiquantitative. Slight changes in the levels of these antibodies should not be relied upon to predict changes in the clinical course of patients with systemic lupus erythematosus (SLE). Clinical flares of disease in patients with SLE may not be accompanied by changes in the levels of dsDNA antibodies. Thus, antibody levels alone are not sufficient to guide disease management.

 

Weak-positive results may not correlate with a diagnosis of SLE. Confirmation with Crithidia luciliae indirect immunofluorescence test (CLIFT), which is more specific for SLE, may be useful to make diagnosis in certain circumstances.

 

A weak-positive dsDNA IgG result by enzyme-linked immunosorbent assay and a CLIFT-negative result may suggest early disease, remission, or false-positive results.

 

False-positive results are usually of low titers.

 

A negative result does not exclude a diagnosis of SLE.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Aringer M, Costenbader K, Daikh D, et al: 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930

2. Petri M, Orbai AM, Alarcon GS, et al: Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473

3. Infantino M, Manfredi M, Merone M, et al: Analytical variability in the determination of anti-double-stranded DNA antibodies: the strong need of a better definition of the old and new tests. Immunol Res. 2018 Jun;66(3):340-347. doi: 10.1007/s12026-018-8992-9

4. Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Ronnelid J, et al: A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: international collaborative study to evaluate a candidate preparation. Ann Rheum Dis. 2019 Dec;78(12):1677-1680. doi: 10.1136/annrheumdis-2019-21584

5. Ambrose N, Morgan TA, Galloway J, et al: Differences in disease phenotype and severity in SLE across age groups. Lupus. 2016 Dec;25(14):1542-1550. doi: 10.1177/0961203316644333

6. Rekvig OP: Autoimmunity and SLE: Factual and semantic evidence-based critical analyses of definitions, etiology, and pathogenesis. Front Immunol. 2020;11:569234. doi: 10.3389/fimmu.2020.569234

7. Bragazzi NL, Watad A, Damiani G, Adawi M, Amital H, Shoenfeld Y: Role of anti-DNA auto-antibodies as biomarkers of response to treatment in systemic lupus erythematosus patients: hypes and hopes. Insights and implications from a comprehensive review of the literature. Expert Rev Mol Diagn. 2019 Nov;19(11):969-978. doi: 10.1080/14737159.2019.1665511

8. Damoiseaux J, Coelho Andrade LE, Carballo OG, et al: Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective. Ann Rheum Dis. 2019 Jul;78(7):879-889. doi: 10.1136/annrheumdis-2018-214436

9. Choi MY, Clarke AE, St Pierre Y, et al: Antinuclear antibody-negative systemic lupus erythematosus in an international inception cohort. Arthritis Care Res (Hoboken). 2019 Jul;71(7):893-902. doi: 10.1002/acr.23712