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Test ID ALDP Autoimmune Liver Disease Panel, Serum

Reporting Name

Autoimmune Liver Disease Panel, S

Useful For

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

Test ID Reporting Name Available Separately Always Performed
AMA Mitochondrial Ab, M2, S Yes Yes
SMA Anti-Smooth Muscle Ab Yes Yes
ANA2 Antinuclear Ab, S Yes Yes

Specimen Type


Specimen Required


Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1.5 mL

Specimen Minimum Volume

1 mL

Specimen Stability Information

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

Reference Values



If positive, results are titered.

Reference values apply to all ages.



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.



Negative: ≤1.0 Units

Weakly positive: 1.1-2.9 Units

Positive: 3.0-5.9 Units

Strongly positive: ≥6.0 Units

Reference values apply to all ages.

CPT Code Information




86256-Smooth muscle antibodies titer (if appropriate)

LOINC Code Information

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


Result ID Test Result Name Result LOINC Value
AMA Mitochondrial Ab, M2, S 51715-1
ANA2 Antinuclear Ab, S 94875-2
6284 Anti-Smooth Muscle Ab 26971-2

Clinical Information

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 was developed through an international collaborative effort.


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.

Clinical Reference

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

Analytic Time

2 days

Method Name

AMA: Enzyme Immunoassay (EIA)

SMA: Indirect Immunofluorescence

ANA2: Enzyme-Linked Immunosorbent Assay (ELISA)


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

Test Classification

See Individual Test IDs

Day(s) and Time(s) Performed

Monday through Saturday