Test Details
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Result 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.
Test Includes
This test includes serial monitoring.
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.
High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
Drug half-life should be taken into consideration when interpreting concentrations measured in non-trough collections. |
Drug half-life should be taken into consideration when interpreting concentrations measured in non-trough collections. High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection. |
References
Custom 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.
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 Instructions
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.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x6 |
Storage Instructions
Refrigerate or freeze
Causes for Rejection
Gross hemolysis; gross lipemia
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 |
| Order Code | 504567 | |||||
| Order Code Name | Vedolizumab Drug + Antibody | |||||
| Order Loinc | 90794-9 | |||||
| Result Code | 504568 | |||||
| Result Code Name | Vedolizumab | |||||
| UofM | ug/mL | |||||
| Result LOINC | 86898-4 | |||||
| Order Code | 504567 | |||||
| Order Code Name | Vedolizumab Drug + Antibody | |||||
| Order Loinc | 90794-9 | |||||
| Result Code | 504569 | |||||
| Result Code Name | Anti-Vedolizumab Antibody | |||||
| UofM | ng/mL | |||||
| Result LOINC | 86899-2 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 504108 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex 1 | ||||||
| Order Code | 504108 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 000000 | |||||
| Result Name | Serial Monitoring | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 504108 | Serial Monitoring | 511958 | 80563-0 | ||
| Reflex 1 | ||||||
| Order Code | 504108 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 511958 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 | |||||