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Adalimumab Anti-drug Antibody for IBD
Test Code36294
CPT Codes
83520<br><strong>This test is not available for New York patient testing</strong>
Preferred Specimen
1 mL serum collected in a red-top tube (no gel)
Patient Preparation
No biotin supplements 48 hours prior to blood draw. Fasting not required.
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: 42 days
Refrigerated: 7 days
Frozen -20°C: 14 days
Frozen -70°C: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Serum separator tube (SST)
Methodology
Enzyme Linked Immunosorbent Assay (ELISA)
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: 2-3 days
Reference Range
<10 AU
Clinical Significance
Detectable serum adalimumab anti-drug antibody may cause accelerated adalimumab clearance leading to reduced trough levels of adalimumab and a compromised clinical response. Patients with low trough adalimumab level and anti-drug antibody are more likely to benefit from a switch in biologic therapy than from an increase in adalimumab dose. If adalimumab level is therapeutic and total adalimumab anti-drug antibody is detected, adalimumab anti-drug antibody may accelerate clearance of the drug, but the detected anti-drug antibody may not be clinically significant. The anti-drug antibody may not be functional or the level is inadequate to accelerate adalimumab clearance. For adalimumab responsive patients, anti-drug antibody may disappear over time or increase, and, if increased, may cause sub-therapeutic adalimumab levels and a loss of response in the future. Addition of immuno-suppressive agents to the treatment regimen may suppress development of anti-drug antibody. Quest Diagnostics adalimumab anti-drug antibody levels are determined with an assay that measures both free and bound anti-drug antibody. Therefore, serum rheumatoid factor will not cause false negative adalimumab anti-drug antibody results.
