Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE™ UST
Also known as: Anti-interleukin antibody drug, Anti-IL12, IL23 inhibitor, Biologic monitoring, therapeutic drug monitoring (TDM), DoseASSURE, Immunogenicity testing, anti-drug antibody, Stelara
Use
Provides ustekinumab drug concentration and anti‐ustekinumab antibodies in order to optimize treatment and facilitate clinical decision‐making.
Special Instructions
High serum biotin concentrations in patients taking biotin supplements may interfere with this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection. Both drug and anti-drug antibody assays have been developed and validated using FDA guidance as a reference.
Limitations
Drug concentration should be interpreted with confirmation of specimen collection timing. Non-trough concentrations may be misleading. Trough blood collection (just before or within 24 hours of the next dose) is suitable because target ranges and therapeutic cut-offs have been established in clinical studies using trough concentration. Positive anti-ustekinumab antibodies should be interpreted in the context of the concomitant free ustekinumab drug level.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 504595
- 504596
- 87408-1
- 88992-3
Result Turnaround Time
11-25 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3 mL
Minimum Volume
1 mL
Container
Red-top tube, gel-barrier tube, plasma EDTA tube, or plasma heparin tube
Collection Instructions
Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube.
Patient Preparation
Stop biotin consumption at least 72 hours prior to sample collection.
Storage Instructions
Frozen (preferred) or refrigerated.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |