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HelpTest ID: FCZAC Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ
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.
Useful 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 |
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.
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
Report Available
10-21 daysmml-gi-ibd, mml-gi-ibd-tdm