Test Details
Methodology
ELISA, IFA, Farr RIA, Turbidimetry, CMIA
Result Turnaround Time
14 - 21 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.
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).
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)
• 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.
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 Instructions
Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping.
Stability Requirements
Temperature | Period |
---|---|
Room temperature | 1 day |
Refrigerated | 8 days |
Frozen | 8 days |
Storage Instructions
Refrigerate.
Causes for Rejection
Grossly hemolyzed, bacterial contamination, lipemic, icteric, non‐serum specimen types
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520073 | Anti-Nuclear Ab by IFA (RDL) | 42254-3 | |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520066 | Anti-Centromere Ab by IFA(RDL) | 5077-3 | |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520060 | Anti-dsDNA Ab by Farr(RDL) | IU/mL | 47299-3 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520216 | Anti-Sm Ab (RDL) | Units | 11090-8 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520217 | Anti-U1 RNP Ab (RDL) | Units | 57662-9 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520218 | Anti-Ro (SS-A) Ab (RDL) | Units | 33569-5 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520225 | Anti-La (SS-B) Ab (RDL) | Units | 45142-7 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520221 | Anti-Scl-70 Ab (RDL) | Units | 26975-3 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520223 | Anti-Cardiolipin Ab, IgG (RDL) | GPL U/mL | 3181-5 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520182 | Anti-Cardiolipin Ab, IgA (RDL) | APL U/mL | 5076-5 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520183 | Anti-Cardiolipin Ab, IgM (RDL) | MPL U/mL | 3182-3 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520169 | C3 Complement (RDL) | mg/dL | 4485-9 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520167 | C4 Complement (RDL) | mg/dL | 4498-2 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520036 | Anti-TPO Ab (RDL) | IU/mL | 8099-4 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520224 | Anti-Chromatin Ab, IgG (RDL) | Units | 32580-3 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520226 | Anti-CCP Ab, IgG + IgA (RDL) | Units | 57093-7 |
520175 | ANA 12Plus Profile, Do All RDL | 97564-9 | 520132 | Rheumatoid Factor by Turb RDL | IU/mL | 11572-5 |
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520073 | |||||
Result Code Name | Anti-Nuclear Ab by IFA (RDL) | |||||
UofM | ||||||
Result LOINC | 42254-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520066 | |||||
Result Code Name | Anti-Centromere Ab by IFA(RDL) | |||||
UofM | ||||||
Result LOINC | 5077-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520060 | |||||
Result Code Name | Anti-dsDNA Ab by Farr(RDL) | |||||
UofM | IU/mL | |||||
Result LOINC | 47299-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520216 | |||||
Result Code Name | Anti-Sm Ab (RDL) | |||||
UofM | Units | |||||
Result LOINC | 11090-8 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520217 | |||||
Result Code Name | Anti-U1 RNP Ab (RDL) | |||||
UofM | Units | |||||
Result LOINC | 57662-9 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520218 | |||||
Result Code Name | Anti-Ro (SS-A) Ab (RDL) | |||||
UofM | Units | |||||
Result LOINC | 33569-5 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520225 | |||||
Result Code Name | Anti-La (SS-B) Ab (RDL) | |||||
UofM | Units | |||||
Result LOINC | 45142-7 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520221 | |||||
Result Code Name | Anti-Scl-70 Ab (RDL) | |||||
UofM | Units | |||||
Result LOINC | 26975-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520223 | |||||
Result Code Name | Anti-Cardiolipin Ab, IgG (RDL) | |||||
UofM | GPL U/mL | |||||
Result LOINC | 3181-5 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520182 | |||||
Result Code Name | Anti-Cardiolipin Ab, IgA (RDL) | |||||
UofM | APL U/mL | |||||
Result LOINC | 5076-5 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520183 | |||||
Result Code Name | Anti-Cardiolipin Ab, IgM (RDL) | |||||
UofM | MPL U/mL | |||||
Result LOINC | 3182-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520169 | |||||
Result Code Name | C3 Complement (RDL) | |||||
UofM | mg/dL | |||||
Result LOINC | 4485-9 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520167 | |||||
Result Code Name | C4 Complement (RDL) | |||||
UofM | mg/dL | |||||
Result LOINC | 4498-2 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520036 | |||||
Result Code Name | Anti-TPO Ab (RDL) | |||||
UofM | IU/mL | |||||
Result LOINC | 8099-4 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520224 | |||||
Result Code Name | Anti-Chromatin Ab, IgG (RDL) | |||||
UofM | Units | |||||
Result LOINC | 32580-3 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520226 | |||||
Result Code Name | Anti-CCP Ab, IgG + IgA (RDL) | |||||
UofM | Units | |||||
Result LOINC | 57093-7 | |||||
Order Code | 520175 | |||||
Order Code Name | ANA 12Plus Profile, Do All RDL | |||||
Order Loinc | 97564-9 | |||||
Result Code | 520132 | |||||
Result Code Name | Rheumatoid Factor by Turb RDL | |||||
UofM | IU/mL | |||||
Result LOINC | 11572-5 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520074 | Homogeneous Pattern | 20398-4 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520074 | |||||
Result Name | Homogeneous Pattern | |||||
UofM | ||||||
Result LOINC | 20398-4 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520076 | Nucleolar Pattern | 20399-2 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520076 | |||||
Result Name | Nucleolar Pattern | |||||
UofM | ||||||
Result LOINC | 20399-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520233 | Speckled Pattern | 20401-6 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520233 | |||||
Result Name | Speckled Pattern | |||||
UofM | ||||||
Result LOINC | 20401-6 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520234 | Centromere Pattern | 53993-2 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520234 | |||||
Result Name | Centromere Pattern | |||||
UofM | ||||||
Result LOINC | 53993-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520235 | Spindle Apparatus Pattern | 53003-0 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520235 | |||||
Result Name | Spindle Apparatus Pattern | |||||
UofM | ||||||
Result LOINC | 53003-0 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520236 | Nuclear Membrane Pattern | 54006-2 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520236 | |||||
Result Name | Nuclear Membrane Pattern | |||||
UofM | ||||||
Result LOINC | 54006-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520237 | Midbody Pattern | 54155-7 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520237 | |||||
Result Name | Midbody Pattern | |||||
UofM | ||||||
Result LOINC | 54155-7 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520238 | Nuclear Dot Pattern | 53998-1 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520238 | |||||
Result Name | Nuclear Dot Pattern | |||||
UofM | ||||||
Result LOINC | 53998-1 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520239 | PCNA Pattern | 53006-3 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520239 | |||||
Result Name | PCNA Pattern | |||||
UofM | ||||||
Result LOINC | 53006-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520240 | Centriole Pattern | 53993-2 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520240 | |||||
Result Name | Centriole Pattern | |||||
UofM | ||||||
Result LOINC | 53993-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520077 | ANA Titer and Pattern | 520241 | Note: | 77202-0 | |
Reflex 1 | ||||||
Order Code | 520077 | |||||
Order Name | ANA Titer and Pattern | |||||
Result Code | 520241 | |||||
Result Name | Note: | |||||
UofM | ||||||
Result LOINC | 77202-0 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 520341 | Repeat Anti-Scl-70 | 520341 | Repeat Anti-Scl-70 | 5348-8 | |
Reflex 1 | ||||||
Order Code | 520341 | |||||
Order Name | Repeat Anti-Scl-70 | |||||
Result Code | 520341 | |||||
Result Name | Repeat Anti-Scl-70 | |||||
UofM | ||||||
Result LOINC | 5348-8 |