Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ
Use
Certolizumab and Anti-Certolizumab Antibody testing is crucial for managing and monitoring patients undergoing treatment with certolizumab pegol, a biologic TNF inhibitor. This test helps in determining the drug and anti-drug antibody levels in the serum, offering insights into the drug's efficacy and immunogenic response. By analyzing these components, clinicians can assess whether the patient is achieving the desired therapeutic levels or if alterations in drug dosing or therapy adjustments are necessary due to suboptimal drug levels or the presence of anti-drug antibodies.
Special Instructions
Patients taking biotin supplements may experience assay interference. It is advised to cease biotin consumption 72 hours prior to specimen collection. Ensure that separate frozen specimens are submitted for each test requested to prevent delays in processing multiple tests.
Limitations
The test measurements are influenced by patient-specific factors such as concurrent medications, disease state, and individual therapeutic goals. Specimen collection timing, especially trough concentrations, is critical for interpreting drug levels based on standard clinical ranges. Moreover, optimal certolizumab concentrations may not always correlate with clinical efficacy due to factors like the presence of anti-drug antibodies or mechanistic failures. These limitations necessitate that test results be considered alongside clinical evaluations and other diagnostic measures.
New York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 87404-0
- 87405-7
Result Turnaround Time
10-21 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
0.6 mL
Container
Plastic vial
Collection Instructions
Allow a minimum clotting time of 30 to 60 minutes. Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial. Send frozen.
Patient Preparation
Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
Causes for Rejection
Gross hemolysis, Gross lipemia, Incorrect specimen type
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 14 days |
| Frozen | 14 days |