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HelpOrder Code VEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum
Ordering Guidance
If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.
Specimen Required
Patient Preparation:
1. For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions:
1. Draw blood immediately before next scheduled dose (trough specimen).
2. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.
Useful For
Assessing the response to therapy with vedolizumab
An aid to achieving desired trough serum concentration of vedolizumab
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 vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Method Name
VEDOL: Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
VEMAB: Electrochemiluminescent Bridging Immunoassay
Reporting Name
Vedolizumab QN, SSpecimen Type
SerumSpecimen 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
Method Description
Vedolizumab Quantitation:
Vedolizumab is extracted from serum and measured by liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.(Cradic KW, Ladwig PM, Rivard AL, Katrangi W, Wintgens KF, Willrich MAV. Vedolizumab quantitation using high-resolution accurate mass-mass spectrometry middle-up protein subunit: Method validation. Clin Chem Lab Med. 2020;58[6]:864-872)
Vedolizumab Antibodies:
Testing for antibodies to vedolizumab is carried out using a laboratory-developed immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.(Unpublished Mayo method)
Day(s) Performed
Monday, Wednesday, Thursday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80280
82397 (if appropriate)
Forms
If not ordering electronically, complete, print, and send 1 of the following with the specimen:
-Gastroenterology and Hepatology Test Request (T728)
-Therapeutics Test Request (T831)