Vedolizumab and Anti-Vedolizumab Antibody, DoseASSURE™ VDZ

CPT: 80280; 82397
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  • Anti-integrin drug
  • Biological monitoring
  • DoseASSURE
  • Entyvio
  • Immunogenicity testing
  • Vedolizumab

Test Includes

This test includes serial monitoring.

Expected Turnaround Time

8 - 15 days

Related Documents

Specimen Requirements


Serum (preferred) or plasma


3 mL

Minimum Volume

1 mL


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


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

Storage Instructions

Refrigerate or freeze

Stability Requirements



Room temperature

14 days


14 days


14 days

Freeze/thaw cycles

Stable x6

Causes for Rejection

Gross hemolysis; gross lipemia

Test Details


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


Drug half-life should be taken into consideration when interpreting concentrations measured in non-trough collections.


Electrochemiluminescence Immunoassay (ECLIA)

Additional Information

In the absence of anti-vedolizumab antibodies, the vedolizumab drug level reflects the total vedolizumab concentration. In the presence of anti-vedolizumab antibodies, the vedolizumab concentration reflects the antibody-unbound fraction of vedolizumab.

The presence of vedolizumab drug, even at concentrations well above target treatment levels , does not interfere with anti-vedolizumab antibody measurement. All positive anti-vedolizumab antibody results are verified by a confirmatory test.


Rosario M, et al. Relationship between vedolizumab pharmacokinetics and endoscopic outcomes in patients with ulcerative colitis. Inflamm Bowel Dis. 2014;20:51-53.


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504567 Vedolizumab Drug + Antibody 90794-9 504568 Vedolizumab ug/mL 86898-4
504567 Vedolizumab Drug + Antibody 90794-9 504569 Anti-Vedolizumab Antibody ng/mL 86899-2
Reflex Table for Anti-Vedolizumab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 000000 Serial Monitoring 000000 Serial Monitoring N/A

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