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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.
Secondary ID
620736Useful 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)
Specimen Type
SerumSpecimen Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
| Heat-treated specimen | Reject |
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.
Method Description
These tests are intended for the semi-quantitative detection of anti-gp210 or anti-Sp100 antibody of the IgG class in human serum. A purified peptide corresponding to a portion of the gp210 or Sp100 protein is bound to the wells of a polystyrene microwell plate. Pre-diluted controls and diluted patient sera are added to separate wells, allowing any gp210 or Sp100 antibodies present to bind to the immobilized antigen. Unbound sample is washed away, and an enzyme labeled anti-human IgG conjugate is added to each well. A second incubation allows the enzyme labeled anti-human IgG to bind to any patient antibodies, which have become attached to the microwells. After washing away any unbound enzyme labeled anti-human IgG, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay can be evaluated spectrophotometrically by measuring and comparing the color intensity that develops in the patient wells with the control in the control wells.(Package inserts: QUANTA Lite gp210 ELISA 708995. INOVA Diagnostics; Rev. 5, 04/2019; QUANTA Lite sp100 ELISA 708990. INOVA Diagnostics; Rev. 3, 12/2018)
Day(s) Performed
Tuesday
Report Available
2 to 8 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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.