Vedolizumab; Vedolizumab Antibodies; Entyvio
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Vedolizumab Quantitation with Reflex to Antibodies, Serum
Test ID: VEDOL S
Test
Aliases/Synonyms
Method
Various - See Method description
Method Description
Vedolizumab Quantitation: liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.
Vedolizumab Antibodies: immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.
Specimens
Serum
Clinical Utility
Assessing the response to therapy with vedolizumab.
An aid to achieving desired trough serum concentration of vedolizumab.
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.
Test Version
19-Nov-2025
Specimen
Specimens
Serum
Collection Containers
Preferred
Red top (no additive)
Acceptable
Acceptable Gold top (clot activator & gel)
Sample Volume
1.5 mL
Minimum Volume
0.3 mL
Patient Preparation
For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.
Collection & Handling
Collection Instructions
Collect specimen immediately before next scheduled dose (trough specimen).
Handling Information
Separate serum within 2 hours of collection.
Additional Information
If Vedolizumab results are 15.0 mcg/mL or less, Vedolizumab Ab will be performed for an additional charge.
Stability
| Refrigerated | 28 days |
|---|---|
| Frozen | 28 days |
Test Version
19-Nov-2025
Performance / Interpretation
Method
Various - See Method description
Method Description
Vedolizumab Quantitation: liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.
Vedolizumab Antibodies: immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.
Turnaround Time
11 days
Results
| Name | Units | Reference Range | Conversion Factor | |
|---|---|---|---|---|
| Vedolizumab Quantitation |
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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 (< or =15 mcg/mL at trough) or undetectable vedolizumab concentration. |
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| Vedolizumab Antibodies | ng/mL |
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Samples containing more than 100 ng/mL biotin (vitamin B7) may interfere (in the form of depressed signal) with Vedolizumab Antibodies.
Clinical management decisions for patients receiving vedolizumab treatment should not be based solely on quantitation of vedolizumab and assessment of Vedolizumab Antibodies if appropriate. Test results must be interpreted within the clinical context of the patient. |
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Test Version
19-Nov-2025
Interface / Setup
Test Version
19-Nov-2025