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Primary Biliary Cholangitis (PBC) Diagnostic Panel
Test CodeCPT Codes
86015, 86038, 86235 (x2), 86381, 86376 (x2)
Includes
Sjögren's Antibodies (SS-A, SS-B)
Mitochondrial Antibody with Reflex to Titer
Actin (Smooth Muscle) Antibody (IgG)
Thyroid Peroxidase Antibody (Anti-TPO)
Liver Kidney Microsome (LKM-1) Antibody (IgG)
If ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).
If Mitochondrial Antibody Screen is positive, then Mitochondrial Antibody Titer will be performed at an additional charge (CPT code(s): 86381).
Preferred Specimen
Minimum Volume
Transport Container
Transport Temperature
Specimen Stability
Refrigerated: 7 days
Frozen: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Immunoassay (IA)
Setup Schedule
Reference Range
Clinical Significance
This panel may be helpful in the diagnostic evaluation of individuals with suspected primary biliary cholangitis (PBC). This panel includes anti-mitochondrial antibody (AMA), with reflex to titer; an antinuclear antibody (ANA) immunofluorescence assay (IFA) screen, performed on human epithelial type 2 (HEp-2) cells, with reflex to titer and pattern; actin (smooth muscle) antibody (SMA; IgG); Sjogren antibodies (SSA, SSB); thyroid peroxidase (TPO) antibody; and liver kidney microsome type 1 (LKM-1) antibody (IgG).
PBC can be diagnosed by fulfilling 2 of the 3 diagnostic criteria that comprise biochemical evidence, histologic evidence, and the presence of PBC-specific antibodies [1]. Presence of AMAs is the serologic hallmark of PBC and can be detected in approximately 95% of patients. ANAs are detected in 10% to 30% of patients with PBC. The presence of certain ANAs patterns including those associated with antibodies to sp100 or gp210 have diagnostic value, especially in AMA-negative PBC [1, 2].
Other antibodies included in this panel may aid in differential diagnosis or identify concomitant autoimmune diseases. Antibodies to SSA and SSB are associated with Sjogren syndrome, an autoimmune disease frequently diagnosed in patients with PBC [1]. SMAs are present in most patients with type 1 autoimmune hepatitis (AIH) but can be detected in a range of other conditions, such as viral hepatitis, malignancies, rheumatic diseases, and nonalcoholic fatty liver disease. LKM-1 antibody is characteristic for type 2 AIH in the absence of hepatitis C. TPO antibodies are associated with autoimmune thyroid disease, which is common in patients with PBC [2]. Note that the presence of these antibodies does not confirm the coexistence of associated autoimmune diseases [1].
The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.
References
1. Lindor KD, et al. Hepatology. 2019;69(1):394-419.
2. Neuberger J, et al, eds. Autoimmune Liver Disease: Management and Clinical Practice. 1st ed. John Wiley & Sons Ltd, 2020
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153