Vedolizumab and Anti-Vedolizumab Antibody, DoseASSURE™ VDZ

CPT: 80280; 82397
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Synonyms

  • 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


Specimen

Serum (preferred) or plasma


Volume

3 mL


Minimum Volume

1 mL


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/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

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

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

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


Methodology

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.


References

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

LOINC® Map

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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