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Test Code GP210 GP210 Antibody, IgG, Serum


Additional Testing Requirements


This is a first line test when primary biliary cholangitis is strongly suspected. This test should be ordered in conjunction with AMA / Mitochondrial Antibodies (M2), Serum and SP100 / SP100 Antibody, IgG, Serum.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 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 gp210 antibodies

 

Estimating risk in AMA-positive patients with incomplete feature of disease

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

GP210 Antibody, IgG, S

Specimen Type

Serum

Specimen 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 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 days

Performing 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GP210 GP210 Antibody, IgG, S 96560-8

 

Result ID Test Result Name Result LOINC Value
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.