PredictrPK® UST Maintenance
Use
The PredictrPK UST Maintenance test predicts trough levels of ustekinumab (UST) and calculates clearance for IBD patients aged 18 and older. It provides dosing insights to ensure sustained therapeutic levels of UST and optimize treatment outcomes.
Special Instructions
Sample collection is flexible post-16 weeks of therapy, any time ≥20 days after a maintenance injection and before trough. Detailed recording of dosing and administration details is needed for optimal test accuracy.
Limitations
This is a laboratory-developed test not cleared or approved by the FDA. It may not account for all sources of PK variability and its effectiveness is based on clinical validation within specific parameters that may not extend to all patient presentations.
Methodology
Immunoassay (Proteomic Panel)
Biomarkers
Result Turnaround Time
3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2.0 mL
Minimum Volume
Not provided
Container
Serum Separator Tube or Red-Top Tube
Collection Instructions
Collect sample ≤3 days before week 16, or any time ≥20 days after a UST maintenance injection.
Storage Instructions
Ambient or cold pack. Do not freeze.
Causes for Rejection
Unlabeled specimens; incorrect tube type
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |