Adalimumab Quantitative, Serum
Use
This test is useful for therapeutic drug monitoring of adalimumab, quantifying adalimumab as part of a profile evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence in inflammatory bowel disease, acute infusion reactions, and proactive monitoring. It helps in distinguishing pharmacokinetic failure from immunogenicity, and aids in rational dose escalation or switching, optimizing long-term exposure, particularly early in therapy and in high-risk patients. Adalimumab is an anti-TNF therapy, used to treat multiple immune-mediated inflammatory diseases.
Special Instructions
This test is not orderable individually and must be ordered as part of a profile (see ADALP / Adalimumab Quantitative with Antibody, Serum). For patient preparation, avoid biotin supplements at least 12 hours before collection to avoid interference. Blood should be drawn immediately before the next dose of drug administration to ensure trough levels. Please refer to the 'Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm' for additional guidance.
Limitations
This test does not differentiate between original and biosimilar products of adalimumab. It is also not suitable for identifying primary nonresponders due to disease processes mediated by molecules other than TNF. The presence of adalimumab in patient serum is a known interference in most antibodies methods, although the acid dissociation step mitigates this interference. The assay methods for Antibodies-to-Adalimumab (ATA) have demonstrated drug tolerance up to specific concentration limits, which should be considered when interpreting results.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 86894-3
- 86894-3
Result Turnaround Time
2-4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.4 mL
Minimum Volume
Not provided
Container
Plastic vial
Collection Instructions
Draw blood immediately before the next dose of drug administration (trough specimen). Centrifuge and aliquot serum into a plastic vial.
Patient Preparation
For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements containing biotin (vitamin B7).
Storage Instructions
Refrigerated (preferred)
Causes for Rejection
Heat-treated sample
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 28 days |
| Frozen | 28 days |