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ANA 12 Plus Profile, Do All (RDL)

CPT: 86038; 86147(x3); 86160(x2); 86200; 86225; 86235(x6); 86256; 86376; 86431

Synonyms

  • ANA 12 Plus
  • ANA 12 Plus Panel

Test Includes

This profile is comprised of Anti‐Nuclear Ab (ANA) by IFA, Anti‐dsDNA Ab by Farr, Anti‐ENA Abs (Anti‐Sm & Anti‐RNP), Anti‐Centromere Ab, C3 & C4 Complements, Anti‐Ro (SS‐A) Ab, Anti‐La (SS‐B) Ab, Anti‐Scl‐70 Ab, Anti‐cardiolipin Abs (IgG, IgA & IgM isotypes), Anti‐TPO (Thyroid Microsomal Peroxidase) Ab, Anti‐Chromatin Ab, Rheumatoid Factor by Turb, Anti‐CCP (Cyclic Citrullinated Peptide) Ab.

The reflexive ANA 12 Plus Profile is a separate test (use 520180).


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 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 andpotential prognostic utility for several autoimmune diseases.

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)


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

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