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For hours, walk-ins and appointments.Vedolizumab and Anti-Vedolizumab Antibody, DoseASSURE™ VDZ
CPT:
80280; 82397
Synonyms
- Anti-integrin drug
- Biological monitoring
- DoseASSURE
- Entyvio
- Immunogenicity testing
- Vedolizumab
Test Includes
This test includes serial monitoring.
Expected Turnaround Time
8 - 15 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.
Related Documents
For more information, please view the literature below.
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 | 504108 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex Table for Anti-Vedolizumab Antibody | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504108 | Serial Monitoring | 511958 | 80563-0 | ||
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