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ANA Profile 12 (RDL)

CPT: 86038
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Updated on 07/31/2020


  • ANA 12
  • ANA 12 Panel

Test Includes

ANA Profile 12 is reflexive and is comprised of Anti-Nuclear Ab (ANA) by IFA, Anti-Cardiolipin Ab (IgG, IgA & IgM Isotypes), Anti-Centromere Ab, Anti-dsDNA Ab by Farr, Anti-La (SS-B) Ab, Anti-Ro (SSA) Ab, Anti-Scl-70 Ab, Anti- Sm, Anti-TPO (Thyroid Microsomal Peroxidase) Ab, Anti-U1 RNP, C3 Complement, C4 Complement.

If ANA is positive, all tests listed are performed. If ANA is negative, an Anti-Ro (SS-A) test is performed to catch the small percentage of ANA false negative results. ANA includes titer & pattern.

Expected Turnaround Time

14 - 21 days

7 days

14 - 21 days

Specimen Requirements




4 mL

Minimum Volume

3 mL (Note: This volume does not allow for repeat testing.)


Red-top tube or gel-barrier tube

Gel tube or red-top tube

Red-top tube or gel-barrier tube


Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping.

Separate serum from cells within one hour. Transfer to a plastic transport tube before freezing.

Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping.

Storage Instructions


Store frozen or refrigerated.


Stability Requirements



Room temperature

8 days


8 days


8 days

Causes for Rejection

Grossly hemolyzed, bacterial contamination, lipemic, icteric, non-serum specimen types

Test Details


The ANA test detects autoantibodies that bind to the nuclear components of HEp-2 cells. A positive ANA titer is not specific, but indicates the presence of one or more autoantibodies. Profiles of specific autoantibodies have diagnostic and potential prognostic utility for several autoimmune diseases.

RDL’s ANA 12 Profile Helps Differentiate Between 8 Autoimmune Disease States:


• ANA by IFA

Tests with high specificity

• Anti-dsDNA by Farr

• Anti-SM

Tests with moderate specificity

• Anti-Ro

• Anti-La

• C3 & C4 Complements

• Anticardiolipin IgG, IgA & IgM

Sjogren’s Syndrome

• Anti-Ro

• Anti-La

Mixed Connective Tissue Disease (MCTD)

• Anti-U1 RNP

Limited Scleroderma (CREST)

• Anti-Centromere

Diffuse Scleroderma

• Anti-SCL-70 by EIA, confirmed by ID

Autoimmune Thyroid Disease


This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.



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