Adalimumab Quantitative with Antibody, Serum
Use
This test is useful for therapeutic drug monitoring of adalimumab. It evaluates 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. Adalimumab is a fully human monoclonal antibody targeting TNF-alpha, a cytokine involved in inflammatory responses in autoimmune diseases.
Special Instructions
This test does not differentiate between originator and biosimilar products. Ordering guidance suggests if both quantitation and antibody levels are needed, this test should be used. Patient preparation involves abstaining from multivitamins or dietary supplements containing biotin for 12 hours before collection.
Limitations
This test cannot distinguish between the reference product Humira and the biosimilar products. There is potential interference from the presence of adalimumab in patient's serum in ATA methods, partially mitigated by an acid dissociation step. It is recommended to draw blood immediately before the next dose of drug administration. Toxicity effects other than acute hypersensitivity infusion reactions haven't been correlated with high adalimumab concentrations.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 99781-7
- 86894-3
- 90779-0
- 77202-0
Result Turnaround Time
3-6 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).
Causes for Rejection
Heat-treated specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 28 days |
| Frozen | 28 days |