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HelpTest Code PBCPN Primary Biliary Cholangitis Antibody Panel, Serum
Test Down Notes
Effective 11/24/2025: This test is temporarily unavailable due to reagent supply issues. The downtime is expected to be 30-45 days. See test notification here for alternatives.
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 Serum
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Useful For
Optimal diagnostic evaluation in at-risk patients for primary biliary cholangitis (PBC)
Early identification of patients at-risk PBC with or without incomplete feature of disease
Reevaluation of PBC 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
Serum: 1.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
Reference Values
MITOCHONDRIAL ANTIBODY, 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 ANTIBODY, 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. Ali AH, Carey EJ, Lindor KD. Diagnosis and management of primary biliary cirrhosis. Expert Rev Clin Immunol. 2014;10(12):1667-1678
2. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419
3. International Consensus on ANA Patterns. AC-20 Cytoplasmic fine speckled. ICAP; 2015. Accessed December 24, 2025. Updated September 2025. 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. Caines A, Lu M, Wu T, et al. Pre-Diagnosis Alkaline Phosphatase and Antimitochondrial Antibody Positivity Vary by Race/Ethnicity Among Patients With Primary Biliary Cholangitis. J Gastroenterol Hepatol. 2025;40(9):2209-2218. doi:10.1111/jgh.17035
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 . Clin Rheumatol. 2020;39(8):2425-2432. doi:10.1007/s10067-020-04950-7
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.