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Vedolizumab Level
Test Code18224
CPT Codes
80280 <br><strong>This this is not available for New York Patient testing</strong>
Preferred Specimen
0.5 mL serum
Minimum Volume
0.35 mL
Instructions
Collect serum immediately before the next scheduled dose (trough specimen)
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: 28 days
Refrigerated: 7 days
Frozen: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Moderate and gross hemolysis
Methodology
Immunoassay (IA)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 3-5 days
Clinical Significance
Vedolizumab is a therapeutic monoclonal antibody against an integrin associated with lymphocyte migration into the gastrointestinal tract. It is used to treat moderate to severe ulcerative colitis and Crohn's disease. Trough concentrations of vedolizumab correlate with the likelihood of clinical remission, but the role of routine monitoring is not clear. Target concentrations may depend on indication, induction vs. maintenance, dosing schedules, drug clearance, and other factors. Induction trough concentrations >35.7 mcg/mL and maintenance trough concentrations >5.1 mcg/mL may be associated with an increased rate of clinical remission [1]. The reportable range is 1.2-60 mcg/mL. This assay may be used to measure approved vedolizumab biosimilars.
1. Restellini S, Khanna R, Afif W. Inflamm Bowel Dis 2018;24:2165-2172
1. Restellini S, Khanna R, Afif W. Inflamm Bowel Dis 2018;24:2165-2172
