Test Catalog

Test Id : ALDG

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Autoimmune Liver Disease Panel, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluation of patients with suspected autoimmune liver disease, specifically autoimmune hepatitis or primary biliary cirrhosis

 

Evaluation of patients with liver disease of unknown etiology

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
AMA Mitochondrial Ab, M2, S Yes Yes
ANA2 Antinuclear Ab, S Yes Yes
SMAS Smooth Muscle Ab Screen, S Yes Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Method Name
A short description of the method used to perform the test

AMA: Enzyme Immunoassay (EIA)

SMAS: Indirect Immunofluorescence

ANA2: Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Autoimmune Liver Disease Panel, S

Aliases
Lists additional common names for a test, as an aid in searching

Antinuclear Antibodies, Serum

Mitochondrial Antibodies, Serum

Primary biliary cirrhosis

Smooth Muscle Antibodies, Serum

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection 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.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluation of patients with suspected autoimmune liver disease, specifically autoimmune hepatitis or primary biliary cirrhosis

 

Evaluation of patients with liver disease of unknown etiology

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Autoimmune liver diseases result from damage to hepatocytes or cholangiocytes caused by an inflammatory immune reaction. Included within this disease group are autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC). In some cases, patients with these diseases may present asymptomatically, with increases in various liver enzymes being identified incidentally during an unrelated clinical evaluation. On the other end of the spectrum are patients who present with clinical evidence of liver disease, including fatigue, hepatomegaly, ascites, esophageal varices, and jaundice.

 

Diagnosis of an autoimmune liver disease first requires that other etiologies of liver injury, including viral, drug, and metabolic causes, be excluded. In some situations, a liver biopsy may be indicated. For those patients in whom an autoimmune liver disease is suspected, autoantibody serology testing may be considered. This assay includes markers that may support a diagnosis of an autoimmune liver disease, specifically AIH or PBC. Unfortunately, there are no known autoantibodies specific for PSC that are useful as diagnostic markers.

 

Patients with AIH may be positive for smooth muscle antibodies (SMA) and/or antinuclear antibodies (ANA). The SMA associated with AIH are generally specific for F-actin. SMA have a specificity of 80% to 90% for AIH, although the sensitivity is only in the range of 70% to 80%. In contrast, ANA, although relatively sensitive for AIH, lack specificity, being associated with a variety of autoimmune diseases. Both SMA and ANA, along with other lab markers and biopsy evaluation, are included in the international diagnostic criteria for AIH.

 

Antimitochondrial antibodies (AMA) are a diagnostic marker for PBC. AMA are found in more than 90% of patients with PBC, with a specificity of greater than 95%. AMA are included in the diagnostic criteria for PBC, which were developed through an international collaborative effort.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

SMOOTH MUSCLE ANTIBODIES

Negative

If positive, results are titered.

Reference values apply to all ages.

 

MITOCHONDRIAL ANTIBODIES (M2)

Negative: <0.1 Units

Borderline: 0.1-0.3 Units

Weakly positive: 0.4-0.9 Units

Positive: > or =1.0 Units

Reference values apply to all ages.

 

ANTINUCLEAR ANTIBODIES (ANA2)

Negative: < or =1.0 Units

Weakly positive: 1.1-2.9 Units

Positive: 3.0-5.9 Units

Strongly positive: > or =6.0 Units

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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.

 

The presence of antimitochondrial antibodies (AMA) is consistent with a diagnosis of primary biliary cirrhosis, in patients with clinical or laboratory evidence of hepatobiliary damage.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Smooth muscle antibodies (SMA) may be found in patients with active hepatitis caused by alcohol or drug exposure.

 

Antinuclear antibodies (ANA) occur in patients with a variety of systemic autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, Sjogren syndrome, and systemic sclerosis.

 

The presence of smooth muscle antibodies (SMA), antinuclear antibodies (ANA), and antimitochondrial antibodies (AMA) should not be exclusively relied upon to diagnose an autoimmune liver disease. Correlation with clinical presentation and other laboratory parameters of liver disease is required.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

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

3. Muratori L, Granito A, Muratori P, et al: Antimitochondrial antibodies and other antibodies in primary biliary cirrhosis: diagnostic and prognostic value. Clin Liver Dis. 2008;12:261-276

4. Karlsen TH, Schrumpf E, Boberg KM: Update on primary sclerosing cholangitis. Dig Liver Dis. 2010;42:390-400

Method Description
Describes how the test is performed and provides a method-specific reference

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; 01/2018)

 

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: The method used to detect antinuclear antibody (ANA) is enzyme-linked immunosorbent assay (ELISA). A HEp-2 lysate supplemented with various purified antigens (double-stranded deoxyribonucleic acid: dsDNA, histone, SS-A [Ro], SS-B [La], Smith, RNP, Scl-70, Jo-1, plus centromere antigen) are coated onto microtiter plate wells. A dilution of patient serum is added to the well and incubated. After washing to remove unbound serum protein, an enzyme conjugated antihuman-IgG antibody is added to detect human IgG bound to the microtiter plate well. After incubation and washing to remove unbound conjugate, a substrate to the enzyme is added to the well. After incubation, the enzyme substrate reaction is stopped. The complete assay is measured on a spectrophotometer plate reader. The optical density measured is proportional to the antibody present in the patient serum.(Package insert: ELISA kits. Bio-Rad Laboratories; 07/2014)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

See Individual Test IDs

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86038

86381

86015

86015-Titer (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ALDG Autoimmune Liver Disease Panel, S 94700-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
AMA Mitochondrial Ab, M2, S 51715-1
ANA2 Antinuclear Ab, S 94875-2
609515 Smooth Muscle Ab Screen, S 26971-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Obsolete Test 2023-06-01