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Adalimumab Level and Anti-drug Antibody for IBD
Test Code36296
CPT Codes
83520, 80145<br><strong>This test is not available for New York patient testing</strong>
Preferred Specimen
2 mL serum collected in a red-top tube (no gel)
Patient Preparation
Patients should refrain from taking biotin supplements or biotin containing vitamins 24-48 hours before blood draw.
The blood should be drawn just before the next infusion of adalimumab to measure the trough drug level.
Minimum Volume
1 mL
Instructions
The blood should be drawn just before the next infusion of adalimumab to measure the trough drug level.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 28 days
Frozen -70° C: 42 days
Refrigerated: 7 days
Frozen: 28 days
Frozen -70° C: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Serum separator tube (SST)
Methodology
Enzyme Linked Immunosorbent Assay (ELISA)
Setup Schedule
Set up: Mon, Tues, Thurs-Sat; Report available: 1-2 days
Clinical Significance
When treatment of inflammatory bowel disease with adalimumab fails, a physician may need to consider treatment options, such as adjusting dose or dosing intervals, switching to a different TNF blocker, or switching to a non-TNF blocker. This test (1) measures adalimumab levels to help differentiate pharmacodynamic or pharmacokinetic conditions to guide therapy, and (2) tests for anti-drug antibodies to help determine if changing the treatment plan is appropriate. The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL.
