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ANA 12 Plus Profile (RDL)

CPT: 86038

Synonyms

  • ANA 12 Plus
  • ANA 12 Plus Panel

Test Includes

ANA 12 Plus Profile is reflexive and consists of the following: Anti‐Nuclear Ab (ANA). If positive, reflexes to following 14 components: Anti-Cardiolipin Ab (IgG, IgA & IgM Isotypes); Anti-Centromere Ab; Anti-Chromatin Ab; Anti-dsDNA Ab by Farr; Anti-La (SS-B) Ab; Anti-Ro (SS-A) Ab; Anti-Scl-70 Ab; Anti-Sm; Anti-TPO (Thyroid Microsomal Peroxidase) Ab; Anti-U1 RNP; C3 Complement; C4 Complement; Rheumatoid Factor by Turb; Anti-CCP (Cyclic Citrullinated Peptide) Ab.

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

ANA 12 Plus Profile, Do All is not reflexive and is a separate test code (use 520175).


Expected Turnaround Time

7-14 days


Specimen Requirements


Specimen

Serum


Volume

4 mL


Minimum Volume

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


Container

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. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Refrigerate or freeze.


Stability Requirements

Temperature

Period

Room temperature

1 day

Refrigerated

8 days

Frozen

8 days


Causes for Rejection

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


Test Details


Use

The ANA 12 Plus Profile is a reflexive assay. If the ANA titer is negative, no further tests are performed except for Anti-Ro Ab. Anti-Ro is performed to find the very small percentage of false negative ANAs. If the ANA titer is positive, the complete profile is performed. 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.

RDL’s ANA 12 Plus 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

• Anti‐Chromatin

• C3 & C4 Complements

• Anticardiolipin IgG, IgA & IgM

Drug‐induced SLE

• Anti‐Chromatin

Sjogren’s Syndrome

• Anti‐Ro

• Anti‐La

Rheumatoid Arthritis

• Anti‐CCP (high specificity)

• Rheumatoid Factor (Turbidimetry)

Mixed Connective Tissue Disease (MCTD)

• Anti-U1 RNP

Limited Scleroderma (CREST)

• Anti-Centomere

Diffuse Scleroderma

• Anti-SCL-70 by EIA, confirmed by ID

Autoimmune Thyroid Disease

• Anti-Thyroid Microsomal (TPO)


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, Turbidimetry, 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