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Test Code ALDG2 Autoimmune Liver Disease Panel, Serum

Test Down Notes

Effective 11/24/2025: This test is temporarily unavailable due to reagent supply issues. The downtime is expected to be 30-45 days. See test notification here for alternatives.


Ordering Guidance


This test should be used for evaluating patients at-risk for antinuclear antibody-associated systemic autoimmune rheumatic disease.



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 Serum

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

Serum: 1.1 mL

Specimen Stability Information

Specimen Type Temperature Time
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. Sebode M, Weiler-Normann C, Liwinski T, Schramm C. Autoantibodies in autoimmune liver disease-clinical and diagnostic relevance. Front Immunol. 2018;9:609

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

3. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419

4. Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 Practice Guidance and Guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020;72(2):671-722

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

6. Dalekos GN, Gatselis NK. Autoimmune serology testing in clinical practice: An updated roadmap for the diagnosis of autoimmune hepatitis. Eur J Intern Med. 2023;108:9-17

7. Colapietro F, Lleo A, Generali E. Antimitochondrial antibodies: From bench to bedside. Clin Rev Allergy Immunol. 2022;63(2):166-177

8. Zhang Q, Liu Z, Wu S, et al. Meta-analysis of antinuclear antibodies in the diagnosis of antimitochondrial antibody-negative primary biliary cholangitis. Gastroenterol Res Pract. 2019;2019:8959103

9. Dahlqvist G, Gaouar F, Carrat F, et al. Large-scale characterization study of patients with antimitochondrial antibodies but nonestablished primary biliary cholangitis. Hepatology. 2017;65(1):152-163

10. Caines A, Lu M, Wu T, et al. Pre-diagnosis alkaline phosphatase and antimitochondrial antibody positivity vary by race/ethnicity among patients with primary biliary cholangitis. J Gastroenterol Hepatol. 2025;40(9):2209-2218. doi:10.1111/jgh.17035

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.