Vedolizumab Quantitation with Antibodies, Serum

Test Code

36517

CPT Codes
80280, 83520

Preferred Specimen

1.5 mL serum

Patient Preparation
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.
Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Minimum Volume

0.75 mL

Instructions

Draw blood immediately before next scheduled dose (trough specimen). Centrifuge within 2 hours of draw.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 28 days
Frozen: 28 days

Methodology
Liquid Chromatography/Mass Spectrometry (LC/MS) • Electrochemiluminescent Bridging Immunoassay

FDA Status
This test was developed and its performance characteristics have been determined by Mayo Clinic Laboratories. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Sets up 4 days a week.

Report Available

Reports in 7 to 14 days.

Clinical Significance

Assessing the unexpected loss of response to therapy with vedolizumab over time. An aid to achieving desired serum levels of vedolizumab.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.