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HelpTest Code VEDOZ Vedolizumab Quantitation with Antibodies, Serum
Reporting Name
Vedolizumab QN with Antibodies, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Assessing for primary or secondary loss of response to therapy with vedolizumab
An aid to achieving desired serum concentrations of vedolizumab
Method Name
VEDOL: Liquid Chromatography Mass Spectrometry (LC-MS/MS)
VEMAB: Electrochemiluminescent Bridging Immunoassay
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.
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.
Specimen 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
Interpretation
The limit of quantitation of the test is 2.0 mcg/mL. In a retrospective Mayo Clinic study with 171 patients (62% Crohn disease, 31% ulcerative colitis, and 7% indeterminate colitis), the median vedolizumab trough concentration was 15.3 mcg/mL.(11) Trough (immediately before next infusion) therapeutic concentrations of vedolizumab are expected to be above 15 mcg/mL.
Vedolizumab concentration greater than 15 mcg/mL at trough is associated with clinical remission, endoscopic remission, or mucosal healing in inflammatory bowel disease.
Clinically significant antibodies-to-vedolizumab impact drug clearance and are associated with low (≤15 mcg/mL at trough) or undetectable vedolizumab concentration.
Day(s) Performed
Vedolizumab Quantitation: Monday, Wednesday, Thursday
Vedolizumab Antibodies: Tuesday, Friday
Report Available
5 to 8 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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 Test Request (T728)
-Therapeutics Test Request (T831)
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.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.