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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

8178

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

DNA Double-Stranded Ab, IgG, S

Specimen Type

Serum

Specimen 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 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.

NY State Approved

Yes