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Order Code LAB5005 Antinuclear Antibodies (ANA), Serum

Additional Codes

Old EPIC Test Code: LABMANA

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 ALDG2 / Autoimmune Liver Disease Panel, Serum.



Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

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.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
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

CPT Code Information

86038

Method Description

The method used to detect antinuclear antibody is enzyme-linked immunosorbent assay (ELISA). A HEp-2 lysate supplemented with specific purified antigens (double-stranded deoxyribonucleic acid, histone, SS-A [Ro], SS-B [La] Smith, sm/RNP, Scl-70, Jo-1, and centromere B antigen) are coated onto microtiter plate wells. A dilution of patient serum is added to the well and incubated. After washing to remove unbound serum protein, an enzyme-conjugated antihuman-IgG antibody is added to detect human IgG bound to the microtiter plate well. After incubation and washing to remove unbound conjugate, a substrate to the enzyme is added to the well. After incubation, the enzyme substrate reaction is stopped. The complete assay is measured on a spectrophotometer plate reader. The optical density measured is proportional to the antibody present in the patient serum. Testing is performed on the Agility instrument by Dynex.(Package insert: ELISA kits. Bio-Rad Laboratories; 07/2014)

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)