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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).
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
1.5 mL (Note: This volume does not allow for repeat testing.)
Red-top tube or gel-barrier tube
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.
Refrigerate or freeze.
Grossly hemolyzed, bacterial contamination, lipemic, icteric, non‐serum specimen types
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:
• ANA by IFA
Tests with high specificity
• Anti‐dsDNA by Farr
Tests with moderate specificity
• C3 & C4 Complements
• Anticardiolipin IgG, IgA & IgM
• Anti‐CCP (high specificity)
• Rheumatoid Factor (Turbidimetry)
Mixed Connective Tissue Disease (MCTD)
• Anti-U1 RNP
Limited Scleroderma (CREST)
• Anti-SCL-70 by EIA, confirmed by ID
Autoimmune Thyroid Disease
• Anti-Thyroid Microsomal (TPO)
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.
ELISA, IFA, Farr RIA, Turbidimetry, CMIA
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