Certolizumab and Anti-Certolizumab Antibody, DoseASSURE™ CTZ
Also known as: Anti-TNF, Anti-TNF drug, Biologic drug level and anti-drug antibody, Biologic monitoring, Cimzia
Use
Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making. This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.
Special Instructions
It is advised to perform trough blood collection, just before the next dose, as target ranges are established by clinical studies evaluating trough concentrations. Patients should avoid biotin supplements for at least 72 hours before sample collection to prevent assay interference.
Limitations
Optimal certolizumab concentration depends on patient-specific factors like co-morbidities and disease characteristics. Trough levels are not absolute indicators of clinical efficacy since non-response could be due to mechanistic factors. The timing of specimen collection affects interpretation, and high serum biotin levels can interfere with the assay.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 87404-0
- 87404-0
- 101724-3
Result Turnaround Time
8-15 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
600 µL
Container
Red-top tube, serum from red-top tube, serum from a gel tube, or serum transfer 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. To avoid delays, submit separate frozen specimens for multiple tests if applicable.
Patient Preparation
Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
Storage Instructions
Refrigerate or freeze.
Causes for Rejection
Gross hemolysis; gross lipemia; incorrect specimen type
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 18 hours |
| Refrigerated | 14 days |
| Frozen | 14 days |