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Adalimumab Level for IBD
Test Code36298
CPT Codes
80145<br /> **This test is not available for New York patient testing**
Preferred Specimen
1 mL serum collected in a red-top tube (no gel)
Patient Preparation
The blood should be drawn just before the next infusion of adalimumab to measure the trough drug level.
Patients should refrain from taking biotin supplements or biotin containing vitamins 24-48 hours before blood draw.
Minimum Volume
0.5 mL
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen -20° C: 14 days
Frozen -70° C: 60 days
Refrigerated: 7 days
Frozen -20° C: 14 days
Frozen -70° C: 60 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
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. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If the steady state trough adalimumab level is low despite adequate dosing, adalimumab anti-drug antibody testing should be considered.
