Order Code LAB5005 Antinuclear Antibodies (ANA), Serum
Additional Codes
Old EPIC Test Code: LABMANA
Reporting Name
Antinuclear Ab, SUseful 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

Specimen Type
SerumOrdering 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)