Vedolizumab and Anti-Vedolizumab Antibody, DoseASSURE™ VDZ

TEST: 504567
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CPT: 80280; 82397
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Synonyms

Anti-Integrin drug Biological monitoring Entyvio Immunogenicity testing Vedolizumab

Expected Turnaround Time

5 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum (preferred) or plasma

Volume

3 mL

Minimum Volume

1 mL (Note: this volume does not allow for repeat testing)

Container

Serum-gel tube, red-top tube, green top (heparin) tube, or lavender top (EDTA) tube

Collection

Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Storage Instructions

Refrigerate or freeze

Stability Requirements

Temperature Period Room Temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycle Stable x6

Causes for Rejection

Gross hemolysis; gross lipemia

Test Details

Use

Provides serum concentrations of vedolizumab and anti-vedolizumab antibodies in order to optimize treatment and facilitate clinical decision making.

Limitations

Failure of vedolizumab therapy may not always be due to the presence of anti-vedolizumab antibodies. Conversely, the absence of anti-vedolizumab antibodies does not guarantee response to treatment.

Methodology

Electrochemiluminescence Immunoassay