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Test Code ALDG2 Autoimmune Liver Disease Panel, Serum


Ordering Guidance


For evaluating patients at-risk for antinuclear antibody-associated systemic autoimmune rheumatic disease, particularly systemic lupus erythematosus, Sjogren syndrome, or mixed connective tissue disease, order CTDC / Connective Tissue Disease Cascade, Serum.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

Evaluating patients with suspected autoimmune liver disease, specifically autoimmune hepatitis or primary biliary cholangitis

 

Evaluating patients with liver disease of unknown etiology

Profile Information

Test ID Reporting Name Available Separately Always Performed
AMA Mitochondrial Ab, M2, S Yes Yes
NAIFA Antinuclear Ab, HEp-2 Substrate, S Yes Yes
SMAS Smooth Muscle Ab Screen, S Yes Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
SMAT Smooth Muscle Ab Titer, S No No

Testing Algorithm

If smooth muscle antibody (SMA) screen is positive, then the SMA titer will be performed at an additional charge.

 

For more information see First-Line Screening for Autoimmune Liver Disease Algorithm.

Method Name

AMA: Enzyme Immunoassay (EIA)

NAIFA, SMAS, SMAT: Indirect Immunofluorescence

Reporting Name

Autoimmune Liver Disease Panel, S

Specimen Type

Serum

Specimen Minimum Volume

1.1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values

MITOCHONDRIAL ANTIBODIES (M2)

Negative: <0.1 Units

Borderline: 0.1-0.3 Units

Weakly positive: 0.4-0.9 Units

Positive: ≥1.0 Units

Reference values apply to all ages.

 

ANTINUCLEAR ANTIBODIES

Negative: <1:80

 

SMOOTH MUSCLE ANTIBODIES

Negative

If positive, results are titered.

Reference values apply to all ages.

Interpretation

The presence of smooth muscle antibodies (SMA) or antinuclear antibodies (ANA) is consistent with a diagnosis of chronic autoimmune hepatitis, in patients with clinical or laboratory evidence of hepatocellular damage.

 

A positive result for antimitochondrial antibodies (AMA) of M2 specificity in the setting of chronic cholestasis after exclusion of other causes of liver disease is highly suggestive of primary biliary cholangitis.

 

Negative results for SMA, ANA, or AMA does not exclude a diagnosis of an autoimmune liver disease.

 

This test is not useful for indicating the stage or prognosis of the disease or for monitoring the course of disease.

Clinical Reference

1. Terziroli Beretta-Piccoli B, Mieli-Vergani G, Vergani D: The clinical usage and definition of autoantibodies in immune-mediated liver disease: A comprehensive overview. J Autoimmun. 2018 Dec;95:144-158. doi: 10.1016/j.jaut.2018.10.0046

2. Mieli-Vergani G, Vergani D, Czaja AJ, et al: Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017

3. Invernizzi P, Lleo A, Podda M: Interpreting serological tests in diagnosing autoimmune liver diseases. Sem Liver Dis. 2007 May;27(2):161-172

4. Terziroli Beretta-Piccoli B, Mieli-Vergani G, Vergani D: Serology in autoimmune hepatitis: A clinical-practice approach. Eur J Intern Med. 2018 Feb;48:35-43

5. Hennes EM, Zeniya M, Czaja AJ, et al: Simplified criteria for the diagnosis of autoimmune hepatitis. Hepatol. 2008 Jul;48(1):169-176

6. Muratori L, Granito A, Muratori P, Pappas G, Bianchi FB: Antimitochondrial antibodies and other antibodies in primary biliary cirrhosis: diagnostic and prognostic value. Clin Liver Dis. 2008 May;12(2):261-276

7. Colapietro F, Lleo A, Generali E: Antimitochondrial antibodies: From bench to bedside. Clin Rev Allergy Immunol. 2022 Oct:63(2):166-177. doi: 10.1007/s12016-021-08904-y 8. Leung PSC, Choi J, Yang G, Woo E, Kenny TP, Gershwin ME: A contemporary perspective on the molecular characteristics of mitochondrial autoantigens and diagnosis in primary biliary cholangitis. Expert Rev Mol Diagn. 2016 Jun;16(6):697-705. doi: 10.1586/14737159.2016.1164038

9. European Association for the Study of the Liver: EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017 Jul;67(1):145-172

Day(s) Performed

Monday through Saturday

Report Available

3 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

See Individual Test IDs

CPT Code Information

86381

86039

86015

86015-Titer (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ALDG2 Autoimmune Liver Disease Panel, S 94700-2

 

Result ID Test Result Name Result LOINC Value
609515 Smooth Muscle Ab Screen, S 26971-2
AMA Mitochondrial Ab, M2, S 51715-1
ANAH Antinuclear Ab, HEp-2 Substrate, S 59069-5
1TANA ANA Titer: 33253-6
1PANA ANA Pattern: 49311-4
2TANA ANA Titer 2: 33253-6
2PANA ANA Pattern 2: 49311-4
CYTQL Cytoplasmic Pattern: 55171-3
LCOM Lab Comment: 77202-0

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Test Request (T728) with the specimen.