Vedolizumab Quantitation with Antibodies, Serum
Test Mnemonic
VEDOLZ
CPT Codes
- 80280 - QTY (1)
- 82397 - QTY (1)
Aliases
- Entyvio
Includes
- Vedolizumab QN, S
- Vedolizumab Ab, S
- VEMAB Interpretation
Performing Laboratory
Mayo Clinic Dpt of Lab Med & Pathology
FDA Category
Laboratory Developed Test
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1.5 mL | Serum | No additive (Red) | Refrigerated | Avoid multivitamins and dietary supplements containing biotin for 12 hours before collection. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to collection. Collect immediately before next scheduled dose (trough specimen). Separate serum from cells ASAP or within 2 hours of collection and transfer to standard aliquot tube. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1.5 mL | Serum | SST (Gold) | Refrigerated | Avoid multivitamins and dietary supplements containing biotin for 12 hours before collection. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to collection. Collect immediately before next scheduled dose (trough specimen). Separate serum from cells ASAP or within 2 hours of collection and transfer to standard aliquot tube. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 0.75 mL |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 28 days |
| Frozen | 28 days |
| Ambient | Unacceptable |
Days Performed
Mon - Fri
Turnaround Time
6 - 9 days
Methodology
| Name | Description |
|---|---|
| Electrochemiluminescent Bridging Immunoassay | |
| Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) |
Reference Range
Special Info
Avoid multivitamins and dietary supplements containing biotin for 12 hours before collection. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to collection. Collect immediately before next scheduled dose (trough specimen). This test is New York State approved.
Clinical Info
This test includes both quantitation and antibody testing. This test is useful in assessing for primary or secondary loss of response to therapy with vedolizumab, or as an aid to achieving desired serum concentrations of vedolizumab. 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.
Clinical Limitation
The presence of high concentrations of vedolizumab might inhibit the antibodies to vedolizumab (ATV) assay yielding false-negative results. Samples containing more than 100 ng/mL biotin (vitamin B7) may interfere with ATV (in the form of depressed signal) for VEMAB / Vedolizumab Antibodies, Serum.