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HelpTest Code FCZAC Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ
Additional Codes
Lab Use Only:
Convert to Blood Misc To Mayo in Cerner
Specimen Required
Specimen Type: Serum
Container/Tube: Red or SST
Specimen Volume: 2 mL
Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube(s) is acceptable. Spin down and send 2 mL of serum frozen in a plastic vial.
To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.
Secondary ID
75563Useful For
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.
Method Name
Electrochemiluminescence immunoassay (ECLIA); Surface Plasmon Resonance
Reporting Name
Certolizumab and Anti-Certo AbSpecimen Type
SerumSpecimen Minimum Volume
0.60 mL (Note: This volume does not allow for repeat testing.)
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 14 days | |
| Refrigerated | 14 days |
Reject Due To
| Gross hemolysis | Gross reject; Mild OK |
| Gross lipemia | Reject |
| Gross icterus | NA |
| Other/Tissue/Swab | Specimens other than indicated |
Reference Values
Certolizumab:
Quantitation Limit: <1.0 ug/mL
Results of 1 ug/mL or higher indicate detection of certolizumab
Anti-Certolizumab Antibody:
Quantitation Limit: <40 ng/mL
Results of 40 ng/mL or higher indicate detection of anti-certolizumab pegol antibodies.
Cautions
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 exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.
Performing Laboratory
Esoterix EndocrinologySpecimen will be sent to Mayo who will forward to Esoterix Ednocrinology for testing.
Test Classification
These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.CPT Code Information
80299
82397
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FCZAC | Certolizumab and Anti-Certo Ab | Not Provided |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| Z5637 | Certolizumab | 87404-0 |
| Z5638 | Anti-Certolizumab Antibody | 87405-7 |
Day(s) Performed
Tuesday