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Test Code VEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum


Advisory Information


This test includes quantitation and, if appropriate, antibody testing will be performed. Therapeutic thresholds for vedolizumab optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

 If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.



Specimen Required


Patient Preparation: 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 draw.


Useful For

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum levels of vedolizumab

 

Monitoring patient compliance

Reflex Tests

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

Testing Algorithm

Vedolizumab quantitation will be performed by liquid chromatography-mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes quantitation and, if appropriate, antibody testing will be performed. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.

Method Name

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

VEMAB: Electrochemiluminescent Bridging Immunoassay

Reporting Name

Vedolizumab QN, S

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

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

Reference Values

VEDOLIZUMAB QUANTITATION :

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES :

Antibodies to vedolizumab: <9.8 ng/mL

Day(s) and Time(s) Performed

VEDOL: Monday, Thursday

VEMAB: Tuesday, Friday

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 U.S. Food and Drug Administration.

CPT Code Information

80299

82397 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOL Vedolizumab QN, S 90805-3

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3

Forms

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