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ANA 12 Plus Profile (RDL)

CPT: 86038
Updated on 02/10/2021
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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

10 - 12 days

14 - 21 days

10 - 12 days


Related Documents


Specimen Requirements


Specimen

Serum


Volume

5 mL

4 mL

5 mL


Minimum Volume

4 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.

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

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

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

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


Storage Instructions

Refrigerate.

Refrigerate.

Refrigerate.

Refrigerate.

Refrigerate.


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


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
520180 ANA 12 Plus Profile (RDL) 520073 Anti-Nuclear Ab by IFA (RDL) 42254-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520066 Anti-Centromere Ab (RDL) 5077-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520060 Anti-dsDNA Ab by Farr(RDL) IU/mL 47299-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520216 Anti-Sm Ab (RDL) Units 11090-8
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520217 Anti-U1 RNP Ab (RDL) Units 57662-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520225 Anti-La (SS-B) Ab (RDL) Units 45142-7
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520221 Anti-Scl-70 Ab (RDL) Units 26975-3
Reflex 3 520043 Confirmatory Anti Scl-70 520043 Confirmatory Anti Scl-70 8092-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520223 Anti-Cardiolipin Ab, IgG (RDL) GPL U/mL 3181-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520182 Anti-Cardiolipin Ab, IgA (RDL) APL U/mL 5076-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520183 Anti-Cardiolipin Ab, IgM (RDL) MPL U/mL 3182-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520169 C3 Complement (RDL) mg/dL 4485-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520167 C4 Complement (RDL) mg/dL 4498-2
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520036 Anti-TPO Ab (RDL) IU/mL 8099-4
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520224 Anti-Chromatin Ab, IgG (RDL) Units 32580-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520226 Anti-CCP Ab, IgG & IgA (RDL) Units 57093-7
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520132 Rheumatoid Factor by Turb RDL IU/mL 11572-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520222 Anti-Ro/Neg ANA 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex 2 520232 ANA 12 Plus, Positive Ro 520231 ANA Plus 12 Interpretation N/A
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520074 Homogeneous Pattern 20398-4
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520076 Nucleolar Pattern 20399-2
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520233 Speckled Pattern 20401-6
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520234 Centromere Pattern 53993-2
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520235 Spindle Apparatus Pattern 53003-0
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520236 Nuclear Membrane Pattern 54006-2
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520237 Midbody Pattern 54155-7
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520238 Nuclear Dot Pattern 53998-1
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520239 PCNA Pattern 53006-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520240 Centriole Pattern 54151-6
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520241 Note: 77202-0
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520066 Anti-Centromere Ab (RDL) 5077-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520060 Anti-dsDNA Ab by Farr(RDL) IU/mL 47299-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520216 Anti-Sm Ab (RDL) Units 11090-8
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520217 Anti-U1 RNP Ab (RDL) Units 57662-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520225 Anti-La (SS-B) Ab (RDL) Units 45142-7
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520221 Anti-Scl-70 Ab (RDL) Units 26975-3
Reflex 2 520043 Confirmatory Anti Scl-70 520043 Confirmatory Anti Scl-70 8092-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520223 Anti-Cardiolipin Ab, IgG (RDL) GPL U/mL 3181-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520182 Anti-Cardiolipin Ab, IgA (RDL) APL U/mL 5076-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520183 Anti-Cardiolipin Ab, IgM (RDL) MPL U/mL 3182-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520169 C3 Complement (RDL) mg/dL 4485-9
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520167 C4 Complement (RDL) mg/dL 4498-2
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520036 Anti-TPO Ab (RDL) IU/mL 8099-4
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520224 Anti-Chromatin Ab, IgG (RDL) Units 32580-3
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520226 Anti-CCP Ab, IgG & IgA (RDL) Units 57093-7
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520132 Rheumatoid Factor by Turb RDL IU/mL 11572-5
Reflex Table for Anti-Nuclear Ab by IFA (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520176 ANA 12 Plus Profile, Positive 520231 ANA Plus 12 Interpretation N/A

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