Adalimumab Drug Level and Anti‑drug Antibody for IBD
Also known as: TNF inhibitor antibody, Anti-TNF inhibitor antibody, Anti-Humira® antibody, Humira® anti-drug antibody
Use
This test measures serum levels of adalimumab and the presence of anti‑adalimumab (anti‑drug) antibodies to assess therapeutic efficacy and immune reaction in patients with inflammatory bowel disease. It supports interpretation of drug trough levels to differentiate between pharmacokinetic failure (low drug level without antibodies), immunogenicity (low drug level with antibodies), adequate drug delivery (therapeutic level without antibodies), and the clinical significance of antibodies when drug levels are adequate. These results help inform dosage adjustment or switching therapy.
Special Instructions
Blood should be drawn just before the next adalimumab infusion (trough level). Patients should refrain from taking biotin supplements or biotin‑containing vitamins for 24–48 hours before blood draw.
Limitations
Gross hemolysis or collection in a serum separator tube (SST) may invalidate the specimen. The assay is a laboratory‑developed ELISA and may not differentiate clinically non‑functional antibodies. Interpretation must be made in the context of clinical presentation and timing relative to drug dosing.
Methodology
Immunoassay (ELISA)
Biomarkers
Result Turnaround Time
2-4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2‑4 mL
Minimum Volume
1 mL
Container
Red‑top tube (no gel)
Collection Instructions
Drawn just before next infusion (trough); avoid biotin supplements 24‑48 hours prior.
Patient Preparation
Refrain from biotin supplements or biotin‑containing vitamins 24‑48 hours before blood draw.
Causes for Rejection
Gross hemolysis; serum separator tube (SST)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48 Hours |
| Refrigerated | 7 Days |
| Frozen | 28 Days (–70 °C: 42 Days) |