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HelpTest Code PBCPN Primary Biliary Cholangitis Antibody Panel, Serum
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
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.
Useful For
Evaluation of at-risk or previously diagnosed primary biliary cholangitis patients with new features of other liver diseases or systemic autoimmune diseases
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| NAIFA | Antinuclear Ab, HEp-2 Substrate, S | Yes | Yes |
| SP100 | SP100 Antibody, IgG, S | Yes | Yes |
| GP210 | GP210 Antibody, IgG, S | Yes | Yes |
| AMA | Mitochondrial Ab, M2, S | Yes | Yes |
Method Name
GP210, SP100: Enzyme-Linked Immunosorbent Assay (ELISA)
AMA: Enzyme Immunoassay (EIA)
NAIFA: Indirect Immunofluorescence
Reporting Name
PBC Comprehensive Antibody Panel, SSpecimen Type
SerumSpecimen Minimum Volume
1.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days |
Reference Values
MITOCHONDRIAL AB, M2
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.
SP100 Antibody, IgG
Negative: ≤20.0 Units
Equivocal: 20.1-24.9 Units
Positive: ≥25.0 Units
GP210 Antibody, IgG
Negative: ≤20.0 Units
Equivocal: 20.1-24.9 Units
Positive: ≥25.0 Units
ANTINUCLEAR AB, HEP-2 SUBSTRATE
Negative: <1:80
Interpretation
Positive results of anti-mitochondrial antibody, anti-Sp100 and/or anti-gp210 antibodies associated with features of cholestatic liver disease is highly suggestive of primary biliary cholangitis. Antinuclear antibody positivity for non-primary biliary cholangitis associated pattern may suggest a coexisting disease requiring additional testing for confirmation.
Clinical Reference
1. Younossi ZM, Bernstein D, Shiffman ML, et al. Diagnosis and management of primary biliary cholangitis. Am J Gastroenterol. 2019;114(1):48-63
2. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. Hepatology. 2019;69(1):394-419
3. International Consensus on ANA Patterns. AC-20 Cytoplasmic fine speckled. ICAP; 2015. Accessed September 15, 2023. Available at www.anapatterns.org/view_pattern.php?pattern=20
4. Zhang Q, Liu Z, Wu S, et al. Meta-analysis of antinuclear antibodies in the diagnosis of antimitochondrial antibody-negative primary biliary cholangitis. Gastroenterol Res Pract. 2019;2019:8959103
5. Dahlqvist G, Gaouar F, Carrat F, et al. Large-scale characterization study of patients with antimitochondrial antibodies but nonestablished primary biliary cholangitis. Hepatology. 2017;65(1):152-163
6. Trivella J, John BV, Levy C. Primary biliary cholangitis: Epidemiology, prognosis, and treatment. Hepatol Commun. 2023;7(6):e0179
7. Nakamura M, Kondo H, Mori T, et al. Anti-gp210 and anti-centromere antibodies are different risk factors for the progression of primary biliary cirrhosis. Hepatology. 2007;45(1):118-127
8. Favoino E, Grapsi E, Barbuti G, et al. Systemic sclerosis and primary biliary cholangitis share an antibody population with identical specificity. Clin Exp Immunol. 2023;212(1):32-38
9. Wei Q, Jiang Y, Xie J, et al. Investigation and analysis of HEp 2 indirect immunofluorescence titers and patterns in various liver diseases [published correction appears in Clin Rheumatol. 2021 Apr;40(4):1667]. Clin Rheumatol. 2020;39(8):2425-2432
10. Munoz-Sanchez G, Perez-Isidro A, Ortiz de Landazuri I, et al. Working algorithms and detection methods of autoantibodies in autoimmune liver disease: A nationwide study. Diagnostics (Basel). 2022;12(3):697
Day(s) Performed
Tuesday
Report Available
2 to 8 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86039
83516 x2
86381
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| PBCPN | PBC Comprehensive Antibody Panel, S | 106054-0 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| AMA | Mitochondrial Ab, M2, S | 51715-1 |
| ANAH | Antinuclear Ab, HEp-2 Substrate, S | 59069-5 |
| SP100 | SP100 Antibody, IgG, S | 96565-7 |
| GP210 | GP210 Antibody, IgG, S | 96560-8 |
| 1TANA | ANA Titer: | 33253-6 |
| 1PANA | ANA Pattern: | 49311-4 |
| 2TANA | ANA Titer 2: | 33253-6 |
| 2PANA | ANA Pattern 2: | 49311-4 |
| CYTQL | Cytoplasmic Pattern: | 55171-3 |
| LCOM | Lab Comment: | 77202-0 |
Forms
If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Test Request (T728) with the specimen.