Adalimumab Drug Level and Anti‑drug Antibody for Rheumatic Diseases
Also known as: TNF inhibitor antibody, Anti-TNF inhibitor antibody, Anti-Humira® antibody, Humira® anti-drug antibody
Use
Quantitative measurement of adalimumab (a TNF‑alpha–targeting monoclonal antibody) trough serum concentrations combined with anti‑adalimumab antibody detection helps assess therapeutic effectiveness or immunogenic failure in patients with rheumatic diseases; low drug levels or presence of anti‑drug antibodies may indicate need for dose adjustment or therapy change.
Special Instructions
Trough (pre‑dose) serum specimen required; patients should abstain from biotin supplementation 24‑48 hours prior to collection (when combined with antibody assay).
Limitations
Analytical performance established under CLIA regulations; not FDA‑cleared or approved; not available for New York State patient testing.
Methodology
Immunoassay (ELISA)
Biomarkers
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
0.5 mL
Container
Red‑top tube (no gel)
Collection Instructions
Draw blood just before the next adalimumab dose (trough); refrain from biotin supplements 24‑48 hours prior to draw.
Causes for Rejection
Gross hemolysis; use of serum separator tube
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48 hours |
| Refrigerated | 7 days |
| Frozen | 8 months for −20 °C; 90 days for −70 °C |
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