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Test Code ADNAR DNA Double-Stranded (dsDNA) Antibodies with Reflex, IgG, Serum

Useful For

Evaluating patients with signs and symptoms consistent with systemic lupus erythematosus (SLE)

Testing Algorithm

If result from dsDNA antibody test by ELISA method is borderline, the dsDNA Ab by Crithidia IFA, IgG test will be performed at an additional charge.

Reporting Name

dsDNA Ab with Reflex, IgG, S

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
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reject Due To

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

NA

Clinical Information

Double-stranded (ds, native) DNA (dsDNA) antibodies of the IgG class are an accepted criterion (American College of Rheumatology) for the diagnosis of systemic lupus erythematosus (SLE).(1-3)

 

dsDNA antibodies are detectable in approximately 85% of patients with untreated SLE, and are rarely detectable in other connective tissue diseases. Weakly positive results caused by low-avidity antibodies to dsDNA are not specific for SLE and can occur in a variety of diseases.

 

Testing for IgG antibodies to dsDNA is indicated in patients who have a positive test for antinuclear antibodies (ANA) along with signs and symptoms that are compatible with the diagnosis of SLE.(2) If the ANA test is negative, there is no reason to test for antibodies to dsDNA.(2)

 

The levels of IgG antibodies to dsDNA in serum are known to fluctuate with disease activity in lupus erythematosus, often increasing prior to an increase in inflammation and decreasing in response to therapy.(1,2)

 

See Connective Tissue Diseases Cascade (CTDC) in Special Instructions.

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.

Interpretation

A positive test result for double-stranded DNA (dsDNA) antibodies is consistent with the diagnosis of systemic lupus erythematosus.

 

A reference range study conducted at the Mayo Clinic demonstrated that, within a cohort of healthy adults (n=120), no individuals between the ages of 18 and 60 (n=78) had detectable anti-dsDNA antibodies. Above the age of 60 (n=42), 11.9% of individuals (n=5) had a borderline result for dsDNA antibodies and 4.8% of individuals (n=2) had a positive result.

Clinical Reference

1. Tran T, Pisetsky D: Chapter 115. Detection of anti-DNA antibodies. In Manual of Molecular and Clinical Laboratory Immunology. Seventh edition. Edited by B Detrick, R Hamilton, JD Folds. Washington, DC, ASM Press, 2006, pp 1027-1032

2. Kavanaugh A, Tomar R, Reveille J, et al: Guidelines for use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. Arch Pathol Lab Med 2000;124:71-81

3. Tan EM, Cohen AS, Fries JF, et al: The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1982;25:1271-1277

Day(s) and Time(s) Performed

Monday through Saturday; 4 p.m.

Analytic Time

2 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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-ADNAR

86255-CRITH (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADNAR dsDNA Ab with Reflex, IgG, S 33799-8

 

Result ID Test Result Name Result LOINC Value
ADNAR dsDNA Ab with Reflex, IgG, S 33799-8

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
CRITH dsDNA Ab by Crithidia IFA, IgG, S No No

Method Name

ADNAR: Enzyme-Linked Immunosorbent Assay (ELISA)

CRITH: Indirect Immunofluorescence