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

Reporting Name

DNA Double-Stranded Ab, IgG, S

Useful For

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

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.

Report Available

1 to 3 days

Day(s) Performed

Monday through Saturday

Clinical Reference

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values

<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.

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86225

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADNA DNA Double-Stranded Ab, IgG, S 33799-8

 

Result ID Test Result Name Result LOINC Value
ADNA DNA Double-Stranded Ab, IgG, S 33799-8

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.

Mayo Clinic Laboratories | Neurology Catalog Additional Information:

mml-Behavioral, mml-Cerebrovascular, mml-Epilepsy, mml-Headache, mml-Movement-Disorders, mml-Demyelinating-Diseases, mml-Neuroimmunology, mml-Neuromuscular, mml-Autonomic, mml-Pediatric, mml-Spinal-Cord