Adalimumab Antibody, Serum
Use
This test is used for therapeutic drug monitoring of adalimumab and quantifying adalimumab antibodies. It is part of a profile evaluating patients for loss of response or partial response to therapy, autoimmune or hypersensitivity reactions, primary nonresponse, and other conditions related to adalimumab treatment. It can aid in monitoring patients undergoing reintroduction after a drug holiday, endoscopic or computed tomography enterography recurrence, acute infusion reactions, and in proactive monitoring. However, it does not differentiate between the originator and biosimilar products.
Special Instructions
The test is only orderable as part of a profile, specifically the ADALP / Adalimumab Quantitative Antibody, Serum. Patient preparation involves abstaining from biotin (vitamin B7) supplements for 12 hours prior to specimen collection.
Limitations
The test cannot distinguish between the reference product Humira and its biosimilars. Adalimumab in patients' serum can interfere with most antibody methods. The test is not suitable for distinguishing between free TNF and TNF bound to monoclonal antibodies. The measurement of TNF is not ideal for monitoring therapy with TNF inhibitors. The presence of antibody-to-adalimumab can potentially neutralize the drug effect and increase drug clearance, requiring adjustments in therapy. Drug tolerance in the assay is noted up to specific concentrations, which should be considered when interpreting results.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 90779-0
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.35 mL
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).
Causes for Rejection
Heat-treated
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 28 days |
| Frozen | 28 days |