Certolizumab and Anti-Certolizumab Antibody, DoseASSURE™ CTZ
CPT:
80299; 82397
Synonyms
- Anti-TNF
- Anti-TNF drug
- Biologic drug level and anti-drug antibody
- Biologic monitoring
- Cimzia
- DoseASSURE
- Immunogenicity testing
- therapeutic drug monitoring (TDM)
- TNF inhibitor
Test Includes
This test includes serial monitoring.
Expected Turnaround Time
8 - 15 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
For more information, please view the literature below.
Rheumatic Diseases Biologics (DoseASSURE™) Flyer
Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Brochure
Biologic Therapeutic Drug Monitoring Q&A
Rheumatoid Arthritis (RA) Comprehensive Testing Brochure
Specimen Requirements
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
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.
Storage Instructions
Refrigerate or freeze.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 18 hours |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x6 |
Causes for Rejection
Gross hemolysis; gross lipemia; incorrect specimen type
Test Details
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.
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 exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.
Methodology
Electrochemiluminescence Immunoassay (ECLIA); Surface Plasmon Resonance
References
Cimzia® [package insert]. Smyrna, GA: UCB Inc; 2016.
Jani M, Isaacs JD, Morgan AW, et al. High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort. Ann Rheum Dis. 2017 Jan;76(1):208-213.27245864
Ramos GP, Al-Bawardy B, Willrich M, et al. Certolizumab Trough Levels And Antibodies In Inflammatory Bowel Disease: A Single-Center Experience. Gastroenterology. 2018 May;154(6):S826-S827.10.1016/S0016-5085(18)32819-1
Sandborn W, Feagan B, Parker G, Bosny P-L, Lee S. The Relationship Between Plasma Concentrations of Certolizumab Pegol and Clinical Efficacy: Results from the PRECiSE 2 Trial. Inflamm Bowel Dis. 2012 Dec;18:S23.10.1097/00054725-201212001-00057
Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017 Sep;153(3):835-857.e6.28774547
Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355.29383030
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 504627 | Certolizumab Drug + Antibody | 87404-0 | 504628 | Certolizumab DRUG Level | ug/mL | 87404-0 |
| 504627 | Certolizumab Drug + Antibody | 87404-0 | 504629 | Anti-Certolizumab Ab Level | ng/mL | 101724-3 |
| Reflex Table for Anti-Certolizumab Ab Level | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 506001 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex Table for Anti-Certolizumab Ab Level | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 506001 | Serial Monitoring | 511958 | 80563-0 | ||
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