Test ID: ADNA DNA Double-Stranded Antibodies, IgG, Serum
Reporting Name
DNA Double-Stranded Ab, IgG, SUseful 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
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.
Interpretation
Weak-positive dsDNA IgG antibody results have a low-positive predictive value for SLE.
Negative results do not rule out a diagnosis of SLE.
Report Available
1 to 3 daysDay(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
SerumSpecimen 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 |
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