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Test Code Billings Clinic: 9554 Mayo: ANA2 Antinuclear Antibodies (ANA), Serum

Reporting Name

Antinuclear Ab, S

Useful For

Evaluating patients at-risk for antinuclear antibodies-associated systemic autoimmune rheumatic disease particularly systemic lupus erythematosus, Sjogren syndrome, and mixed connective tissue disease

Testing Algorithm

For more information see Connective Tissue Disease Cascade.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Ordering Guidance


If suspicious of connective tissue disorder, see CTDC / Connective Tissue Disease Cascade, Serum.

 

If suspicious of autoimmune liver disease, see ALDG / Autoimmune Liver Disease Panel, Serum.



Specimen Required


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.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Special Instructions

Reference Values

Negative: ≤1.0 U

Weakly positive: 1.1-2.9 U

Positive: 3.0-5.9 U

Strongly positive: ≥6.0 U

Reference values apply to all ages.

Day(s) Performed

Monday through Saturday

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

86038

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ANA2 Antinuclear Ab, S 94875-2

 

Result ID Test Result Name Result LOINC Value
ANA2 Antinuclear Ab, S 94875-2

Interpretation

A large number of healthy individuals have weakly-positive (1.1-2.9 U) antinuclear antibody (ANA) enzyme-linked immunosorbent assay (ELISA) results, many of which are likely to be clinical false-positive results; therefore, second-order testing of all positive ANA yields a very low percentage of positive results to extractable nuclear antigens including double-stranded (ds) DNA.(2)

 

Positive ANA results greater than 3.0 U are associated with the presence of detectable autoantibodies to specific extractable nuclear antigens (SM, SS-A, SS-B, Sm/RNP or RNP 68 and RNP A, Jo-1, Scl-70) including dsDNA.

Report Available

1 day

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Gastroenterology and Hepatology Test Request (T728)

-Renal Diagnostics Test Request (T830)