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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
7 - 10 days
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.
Related Documents
For more information, please view the literature below.
Antinuclear Antibodies Testing Options in Rheumatology Brochure
Specimen Requirements
Specimen
Serum
Volume
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.
Storage Instructions
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 by IFA(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 | 520341 | Repeat Anti-Scl-70 | 520341 | Repeat Anti-Scl-70 | 5348-8 | |
| 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 | 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 | 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 | 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 by IFA(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 | 520341 | Repeat Anti-Scl-70 | 520341 | Repeat Anti-Scl-70 | 5348-8 | |
| 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 | 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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The LOINC® codes are copyright © 1994-2021, 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