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Adalimumab Level
Test Code36298
CPT Codes
80145
Preferred Specimen
0.5 mL serum
Patient Preparation
Collect immediately before next scheduled dose (trough specimen)
Minimum Volume
0.35 mL
Instructions
Draw blood in non-separator gel tube (red-top) or separator gel tube (SST). Centrifuge and transfer serum to a labeled plastic transport tube.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 8 days
Frozen: 30 days
Refrigerated: 8 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Moderate and gross hemolysis
Methodology
Chemiluminescent Immunoassay
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon, Tues, Thurs-Sat; Report available: 4-6 days
Reference Range
See Laboratory Report
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.
