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Test Code ADNA1 Double-Stranded DNA (dsDNA) Antibodies, IgG, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.3 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

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

 

Monitoring disease activity, as an adjunct test, in patients with SLE previously positive for double-stranded DNA IgG antibodies

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

dsDNA Ab, IgG, S

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Systemic lupus erythematosus (SLE) is a chronic autoimmune condition in which an inflammatory immune response leads to damage of a variety of organ systems, including the skin, joints, kidney, vasculature, lungs, and brain. In 2019, the European League Against Rheumatism/American College of Rheumatology published classification criteria for SLE,(1) which includes antibodies to double-stranded DNA (dsDNA) as an SLE-specific autoantibody within the immunology domain. Anti-dsDNA antibodies are also included in the Systemic Lupus International Collaborating Clinics classification criteria (SLICC) for SLE.(2) Detection of IgG antibodies to dsDNA is the most clinically useful isotype.(3-5) The diagnostic performance of dsDNA IgG antibodies in SLE is variable and dependent on several factors, including the immunological method used for their detection, the structure of the DNA antigen, the patient's disease state (early or active vs inactive), and specific clinical manifestations and patient demographics.(3-7) Weak-positive dsDNA IgG antibodies having low affinity and low avidity display variable clinical correlations with SLE.(3)

 

Testing for IgG antibodies to dsDNA is indicated in patients with clinical features compatible with SLE who are positive for anti-cellular antibody (antinuclear antibody: ANA), particularly the homogeneous pattern identified using HEp-2 substrate by indirect immunofluorescence assay (IFA).(1,2,8) A minority of SLE patients may test negative using HEp-2 by IFA for nuclear antibodies.(8,9) For patients with features of neuropsychiatric disease, testing for antibodies associated with HEp-2 IFA cytoplasmic patterns such as ribosomal P IgG autoantibodies may be useful. In addition, some patients may benefit from testing for additional markers, including Smith, ribonucleoprotein, SSA-52, and SSA-60 antibodies.(8,9)

 

The reactivity of antibodies to dsDNA may fluctuate with SLE disease activity. Increasing reactivity may be associated with flares while a decline or seronegativity may indicate response to treatment or disease remission.

 

For more information see First-Line Screening for Autoimmune Liver Disease Algorithm.

Reference Values

<100 IU/mL (negative)

≥100 IU/mL (positive)

Negative is considered normal.

Reference values apply to all ages.

Day(s) Performed

Monday through Saturday

Report Available

2 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

Forms

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