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Test ID PBC2 SP100 and GP210 Antibodies, IgG, Serum

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Additional Testing Requirements


This is a first line test when primary biliary cholangitis is strongly suspected. It should be ordered in conjunction with testing for mitochondrial antibodies (M2) (AMA / Mitochondrial Antibodies [M2], Serum) and antinuclear antibodies (NAIFA / Antinuclear Antibodies, HEp-2 Substrate, IgG, 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 Serum

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Reporting Name

SP100 and GP210 Antibodies, IgG, S

Specimen Type

Serum

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Report Available

2 to 8 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

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

Testing Algorithm

For information see First-Line Screening for Autoimmune Liver Disease Algorithm.

Day(s) Performed

Tuesday

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

Profile Information

Test ID Reporting Name Available Separately Always Performed
SP100 SP100 Antibody, IgG, S Yes Yes
GP210 GP210 Antibody, IgG, S Yes Yes

Specimen Minimum Volume

Serum: 0.4 mL

Reference Values

Negative: ≤20.0 Units

Equivocal: 20.1-24.9 Units

Positive: ≥25.0 Units