Primary Biliary Cholangitis Antibody Panel, Serum

Clinical Use

Use

The Primary Biliary Cholangitis (PBC) Antibody Panel is used for the optimal diagnostic evaluation in at-risk patients for PBC. It aids in the early identification of patients at risk of PBC with or without incomplete features of the disease. Additionally, it is useful for the reevaluation of PBC patients exhibiting new features of other liver diseases or systemic autoimmune diseases. This test includes antibodies diagnostic for PBC, assists in confirming PBC diagnosis, predicts the development of the disease in preclinical cases, and helps in risk stratification and prognosis.

Special Instructions

Not provided.

Limitations

Serologic tests for autoantibodies, including anti-gp210 and anti-Sp100, should not be relied upon exclusively to determine the etiology or prognosis of PBC. Correlations between these antibodies for specific HEp-2 immunofluorescence assay patterns are variable. Negative results for anti-gp210 antibodies and/or anti-Sp100 antibodies do not exclude a PBC diagnosis. Positive results for antimitochondrial antibodies of M2 specificity are sometimes seen in those with systemic sclerosis or individuals without clinical evidence of systemic autoimmune rheumatic disease.

Test Details

FDA Approved

New York Approved

Methodology

Immunoassay

Biomarkers

4 components

Mitochondrial Antibodies, M2 • EIAAntinuclear Antibodies, HEp-2 Substrate • Indirect ImmunofluorescenceSP100 Antibody, IgG • ELISAGP210 Antibody, IgG • ELISA