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HelpTest 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.
Secondary ID
619516Useful 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
Specimen Type
SerumSpecimen Minimum Volume
1.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| 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.
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.
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
Report Available
3 to 4 daysSpecimen Retention Time
14 daysPerforming 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.