Test ID ADNA DNA Double-Stranded Antibodies, IgG, Serum
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Secondary ID
8178Useful 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
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
DNA Double-Stranded Ab, IgG, SSpecimen Type
SerumSpecimen Minimum Volume
0.35 mL
Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Serum | Refrigerated (preferred) | 21 days |
Frozen | 21 days |
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.
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.
Cautions
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.
Day(s) Performed
Monday through Saturday
Report Available
2 to 4 daysPerforming Laboratory
