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ANA 12 Plus Profile, Do All (RDL)

CPT: 86038; 86147(x3); 86160(x2); 86200; 86225; 86235(x6); 86256; 86376; 86431
Updated on 02/10/2021
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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

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 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)

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)

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)

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)

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.


Methodology

ELISA, IFA, Farr RIA, Turbidimetry, CMIA


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
520175 ANA 12Plus Profile, Do All RDL 520073 Anti-Nuclear Ab by IFA (RDL) 42254-3
520175 ANA 12Plus Profile, Do All RDL 520066 Anti-Centromere Ab (RDL) 5077-3
520175 ANA 12Plus Profile, Do All RDL 520060 Anti-dsDNA Ab by Farr(RDL) IU/mL 47299-3
520175 ANA 12Plus Profile, Do All RDL 520216 Anti-Sm Ab (RDL) Units 11090-8
520175 ANA 12Plus Profile, Do All RDL 520217 Anti-U1 RNP Ab (RDL) Units 57662-9
520175 ANA 12Plus Profile, Do All RDL 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
520175 ANA 12Plus Profile, Do All RDL 520225 Anti-La (SS-B) Ab (RDL) Units 45142-7
520175 ANA 12Plus Profile, Do All RDL 520221 Anti-Scl-70 Ab (RDL) Units 26975-3
520175 ANA 12Plus Profile, Do All RDL 520223 Anti-Cardiolipin Ab, IgG (RDL) GPL U/mL 3181-5
520175 ANA 12Plus Profile, Do All RDL 520182 Anti-Cardiolipin Ab, IgA (RDL) APL U/mL 5076-5
520175 ANA 12Plus Profile, Do All RDL 520183 Anti-Cardiolipin Ab, IgM (RDL) MPL U/mL 3182-3
520175 ANA 12Plus Profile, Do All RDL 520169 C3 Complement (RDL) mg/dL 4485-9
520175 ANA 12Plus Profile, Do All RDL 520167 C4 Complement (RDL) mg/dL 4498-2
520175 ANA 12Plus Profile, Do All RDL 520036 Anti-TPO Ab (RDL) IU/mL 8099-4
520175 ANA 12Plus Profile, Do All RDL 520224 Anti-Chromatin Ab, IgG (RDL) Units 32580-3
520175 ANA 12Plus Profile, Do All RDL 520226 Anti-CCP Ab, IgG & IgA (RDL) Units 57093-7
520175 ANA 12Plus Profile, Do All RDL 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 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 520077 ANA Titer and Pattern 520241 Note: 77202-0
Reflex Table for Anti-Scl-70 Ab (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520043 Confirmatory Anti Scl-70 520043 Confirmatory Anti Scl-70 8092-9

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CPT Statement/Profile Statement

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