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HelpTest Code PBC2 SP100 and GP210 Antibodies, IgG, Serum
Additional Testing Requirements
This is a first line test when primary biliary cholangitis is strongly suspected. It should be ordered in conjunction with AMA / Mitochondrial Antibodies (M2), 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: 1.0 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Useful For
Evaluating the risk of primary biliary cholangitis in anti-mitochondrial antibody (AMA)-negative patients by identification of Sp100 and gp210 antibodies
Estimating risk in AMA-positive patients with incomplete feature of disease
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| SP100 | SP100 Antibody, IgG, S | Yes | Yes |
| GP210 | GP210 Antibody, IgG, S | Yes | Yes |
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
SP100 and GP210 Antibodies, IgG, SSpecimen Type
SerumSpecimen Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days |
Reference Values
Negative: ≤20.0 Units
Equivocal: 20.1-24.9 Units
Positive: ≥25.0 Units
Interpretation
A positive result for anti-gp210 antibodies or anti-Sp100 antibodies in the setting of chronic cholestasis after exclusion of other causes of liver disease is highly suggestive of primary biliary cholangitis.
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. 2019;69(1):394-419
3. International Consensus on ANA Patterns. AC-20 Cytoplasmic fine speckled. ICAP; 2015. Accessed August 18, 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. 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
7. Jaskowski TD, Nandakumar V, Novis CL, Palmer M, Tebo AE. Presence of anti-gp210 or anti-sp100 antibodies in AMA-positive patients may help support a diagnosis of primary biliary cholangitis. Clin Chim Acta. 2023;540:117219
8. 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;12:697
9. 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
10. 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. doi:10.1007/s10067-020-04950-7
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
83516 x 2
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| PBC2 | SP100 and GP210 Antibodies, IgG, S | 106055-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SP100 | SP100 Antibody, IgG, S | 96565-7 |
| GP210 | GP210 Antibody, IgG, S | 96560-8 |
Forms
If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Test Request (T728) with the specimen.
Testing Algorithm
For more information see First-Line Screening for Autoimmune Liver Disease Algorithm.