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ANA Profile 12 (RDL)

CPT: 86038
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86038
Updated on 07/31/2020

Synonyms

  • 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


Specimen

Serum


Volume

4 mL


Minimum Volume

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


Container

Red-top tube or gel-barrier tube

Gel tube or red-top tube

Red-top tube or gel-barrier tube


Collection

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

Refrigerate.

Store frozen or refrigerated.

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

8 days

Refrigerated

8 days

Frozen

8 days


Causes for Rejection

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


Test Details


Use

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:

SLE

• 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


Limitations

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


Methodology

ELISA, IFA, Farr RIA,CMIA


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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf