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Primary Biliary Cirrhosis (PBC) Profile (RDL)

CPT: 83516; 83520(x2); 86038; 86256

Test Includes

Anti-Nuclear Ab by IFA; Anti-Mitochondrial Ab (IFA); Anti-Mitochondrial M2 Ab by EIA; Anti-GP-210; Anti-SP-100


Expected Turnaround Time

14 - 21 days


Specimen Requirements


Specimen

Serum


Volume

3 mL


Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Collection

Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Refrigerate or freeze.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

14 days

Frozen

60 days

Freeze/thaw cycles

Stable x1


Causes for Rejection

Grossly hemolyzed; bacterial contamination; lipemic specimen; icteric specimen; non-serum specimen types


Test Details


Use

Primary biliary cirrhosis (PBC) is an organ-specific autoimmune disease characterized by chronic progressive destruction of small intrahepatic bile ducts with portal inflammation and ultimately fibrosis. PBC affects women more than men and typically occurs between the ages of 30 and 65. PBC affects women more than men and typically occurs between the ages of 30 and 65. The prevalence of PBC in first-degree relatives of PBC patients range is from 1.3 to 6.4%.

Anti-mitochondrial antibodies (AMA) have been reported in 90-96% of patients with primary biliary cirrhosis (PBC). AMA are also occasionally found in other liver conditions, including chronic active hepatitis, cryptogenic cirrhosis and in sera of individuals with clinical but no biochemical evidence of liver disease.

Serologic assays are important aids to the recognition and diagnosis of PBC since many antibodies associated with PBC are present before symptoms become evident. Anti-GP-210 and Anti-SP-100 antibodies have relatively low sensitivity, but specificity greater than 99% and either is detected in approximately 25% of all PBC patients and 30% of AMA-negative PBC patients. Additionally, these antibodies may identify a subgroup of patients with a more severe disease course.

Combined testing for the three markers, Anti-M2, Anti-GP- 210 and Anti-SP-100, identified 92% of PBC patients.


Limitations

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

Indirect fluorescent antibody (IFA), Enzyme Immunoassay (EIA)


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