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Test Code VEDOZ Vedolizumab Quantitation with Antibodies, Serum


Ordering Guidance


If there is a known justification for performing both quantitation and antibody levels, this is the correct test to order. If there is not a known reason to perform the antibodies component, consider VEDOL / Vedolizumab Quantitation with Reflex to Antibodies, Serum. VEDOL testing begins with vedolizumab quantitation When the quantitation results are 15.0 mcg/mL or less, testing for antibodies to vedolizumab will be performed.



Specimen Required


Patient Preparation:

1. For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

 

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1.5 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose (trough specimen).

2. Centrifuge within 2 hours of collection.


Useful For

Assessing for primary or secondary loss of response to therapy with vedolizumab

 

An aid to achieving desired serum concentrations of vedolizumab

Profile Information

Test ID Reporting Name Available Separately Always Performed
VEDOL Vedolizumab QN, S Yes Yes
VEMAB Vedolizumab Ab, S No Yes

Testing Algorithm

When this test is ordered, vedolizumab quantitation and testing for antibodies to vedolizumab will always be performed.

 

This test includes both quantitation and antibody testing on all specimens. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. Currently the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab.

Method Name

VEDOL: Liquid Chromatography-Mass Spectrometry (LC-MS/MS)

VEMAB: Electrochemiluminescent Bridging Immunoassay

Reporting Name

Vedolizumab QN with Antibodies, S

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation=2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

Day(s) Performed

Vedolizumab Quantitation: Monday, Thursday

Vedolizumab Antibodies: Tuesday, Friday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80280

82397

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOZ Vedolizumab QN with Antibodies, S 90794-9

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3
603298 Vedolizumab Ab, S 86899-2
603299 VEMAB Interpretation 59462-2

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Client Test Request (T728)

-Therapeutics Test Request (T831)