Adalimumab Quantitative with Reflex to Antibody, Serum
Use
This test is used for therapeutic drug monitoring of adalimumab and is helpful for evaluating patients who exhibit loss of response or partial response upon initiation of therapy. It is also useful in cases of autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after a drug holiday, recurrence of symptoms in inflammatory conditions, acute infusion reactions, and proactive monitoring including reflex testing for antibodies to adalimumab. The test does not differentiate between the originator and biosimilar products.
Special Instructions
The patient should avoid taking multivitamins or dietary supplements containing biotin for 12 hours before specimen collection. Blood should be drawn immediately before the next dose of drug administration (trough specimen).
Limitations
This test does not distinguish between the reference product Humira and its biosimilars. Tumor necrosis factor (TNF) measurement is unsuitable for monitoring therapy with TNF inhibitors as it cannot differentiate between free TNF and TNF bound to antibodies. Adalimumab assay interference by ADL in serum is mitigated by an acid dissociation step in the ATA assay. Performing the blood draw at trough is recommended for therapeutic drug monitoring.
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
0.5 mL
Minimum Volume
0.35 mL
Container
Serum gel (preferred) or red top, submit in 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, the patient should not take multivitamins or dietary supplements containing biotin.
Causes for Rejection
Heat-treated specimen
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 28 days |
| Frozen | 28 days |