Order 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
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, SSpecimen Type
SerumSpecimen Minimum Volume
1.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
| Heat-treated specimen | Reject |
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.
Method Description
Mitochondrial Antibodies:
This method is an enzyme immunosorbent assay that detects both IgG and IgM antibodies to M2 antigens. A dilution of patient serum is added to the wells coated with M2 antigen and incubated. After incubation and washing, all unbound human antibodies are washed away, and enzyme-conjugated IgG and IgM anti-human is added. The enzyme conjugate binds to the antibody complex. Excess enzyme-conjugate is washed away, and substrate is added. After incubation, the enzyme substrate reaction is stopped. The complete assay is measured on a spectrophotometer plate reader. The intensity of the color generated is proportional to the amount of IgG and IgM specific antibody in the sample.(Package insert: Kallestad Anti-Mitochondrial Kit. Bio-Rad Laboratories; 10/2014)
Antinuclear Antibodies:
Antibodies to nuclear antigens in a human epithelial type 2 (HEp-2) cell line by an indirect immunofluorescent technique. Commercial slides prepared from HEp-2 cells are used as a substrate. IgG antibodies in serum specimens are detected after incubation of serum with the commercial slides by the addition of a fluorescein isothiocyanate (FITC)-labeled antihuman-IgG reagent. All patient specimens are initially screened at 1:80.(Package insert: NOVA Lite DAPI ANA. Inova Diagnostics; 06/2018)
Smooth Muscle Antibody:
The patient's serum in 1:20 and 1:40 dilutions is added to fresh tissue from mouse stomach/kidney and incubated; fluorescein-conjugated antiglobulin is then added. The slides are read with a fluorescence microscope.(Package insert: Kallestad Mouse Stomach/Kidney. Bio-Rad Laboratories, Inc; 06/2015)
Day(s) Performed
Monday through Saturday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
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.