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Test ID ANA2 Antinuclear Antibodies (ANA), Serum

Useful For

Evaluating patients suspected of having a systemic rheumatic disease

Testing Algorithm

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Antinuclear Ab, S

Specimen Type

Serum

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms: If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf).

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Clinical Information

Measurement of antinuclear antibodies (ANAs) in serum is the most commonly performed screening test for patients suspected of having a systemic rheumatic disease, also referred to as connective tissue disease.(1) ANAs occur in patients with a variety of autoimmune diseases, both systemic and organ-specific. They are particularly common in the systemic rheumatic diseases, which include lupus erythematosus (LE), discoid LE, drug-induced LE, mixed connective tissue disease, Sjogren syndrome, scleroderma (systemic sclerosis), CREST (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome, polymyositis/dermatomyositis, and rheumatoid arthritis.(1)

 

The diagnosis of a systemic rheumatic disease is based primarily on the presence of compatible clinical signs and symptoms. The results of tests for autoantibodies including ANA and specific autoantibodies are ancillary. Additional diagnostic criteria include consistent histopathology or specific radiographic findings. Although individual systemic rheumatic diseases are relatively uncommon, a great many patients present with clinical findings that are compatible with a systemic rheumatic disease and large numbers of tests for ANA are ordered to eliminate the possibility of a systemic rheumatic disease.

 

See Connective Tissue Diseases Cascade Test-Ordering Algorithm in Special Instructions, also see Optimized Laboratory Testing for Connective Tissue Diseases in Primary Care: The Mayo Connective Tissue Diseases Cascade in Publications.

Reference Values

≤1.0 U (negative)

1.1-2.9 U (weakly positive)

3.0-5.9 U (positive)

≥6.0 U (strongly positive)

Reference values apply to all ages.

Cautions

Some patients without clinical evidence of an autoimmune disease or a systemic rheumatic disease may have a detectable level of antinuclear antibody (ANA). This finding is more common in women than men, and the frequency of a detectable ANA in healthy women >40 years old may approach 15% to 20%. ANA may also be detectable following viral illnesses, in chronic infections, or in patients treated with many different medications.

Day(s) Performed

Monday through Friday, Saturday; 11 a.m.

Report Available

1 day

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

86038

NY State Approved

Yes