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Test Code SP100 SP100 Antibody, 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 and GP210 / GP210 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.


Secondary ID

620725

Useful For

Evaluating the risk of primary biliary cholangitis in anti-mitochondrial antibody (AMA) negative patients by identification of Sp100 antibodies

 

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-treated specimens Reject

Reference Values

Negative: ≤20.0 Units

Equivocal: 20.1-24.9 Units

Positive: ≥25.0 Units

Interpretation

A positive result for 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

This test is intended for the semi-quantitative detection of anti-Sp100 antibody of the IgG class in human serum. A purified peptide corresponding to a portion of the 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 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 insert: QUANTA Lite sp100 ELISA 708990. INOVA Diagnostics; Rev. 3, 12/2018)

Day(s) Performed

Tuesday

Report Available

2 to 8 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

83516

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SP100 SP100 Antibody, IgG, S 96565-7

 

Result ID Test Result Name Result LOINC Value
SP100 SP100 Antibody, IgG, S 96565-7

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Test Request (T728) with the specimen.