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Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ
Test CodeLAB01225
Alias/See Also
LAB01225
LabCorp TC: 504627
Anti-TNF drug
Cimzia
TNF inhibitor
LabCorp TC: 504627
Anti-TNF drug
Cimzia
TNF inhibitor
CPT Codes
80299, 82397
Includes
Certolizumab Drug Level
Anti-Certolizumab Antibody
Anti-Certolizumab Antibody
Preferred Specimen
2mL Serum
(Marble, Gold, Red)
(Marble, Gold, Red)
Minimum Volume
0.5 mL
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 in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Transport Temperature
Frozen
Specimen Stability
Frozen: 14 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis, gross lipemia, incorrect speicmen type
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Report Available
8-15 days
Limitations
As with other biologics, the optimal certolizumab concentration depends upon patient-specific factors including co-morbidities, disease, and desired therapeutic endpoint.
Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.
Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.
Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.
Lack of clinical response may be due to inadequate drug expsure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.
Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.
Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.
Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.
Lack of clinical response may be due to inadequate drug expsure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.
Clinical Significance
Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and faciliate clinical decision-making. This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.
Performing Laboratory
LabCorp