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
Not provided.
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
Anti-Ustekinumab Antibody
AntibodyUstekinumab
Analyte
LOINC Codes
- 504595
- 504596
- 87408-1 - Ustekinumab SerPl IA-mCnc
- 88992-3 - Ustekinumab Ab SerPl IA-mCnc
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 |
Other tests from different labs that may be relevant