Infliximab Anti-Drug Antibody

Test Code
36301


Preferred Specimen
Red Top 


Patient Preparation
Dietary supplements containing biotin may interfere in assays and may skew results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega-doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation.

Collect immediately before next scheduled dose (trough specimen).

Minimum Volume
0.5 mL


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 48 hours
Refrigerated: 14 days
Frozen -20° C: 28 days
Frozen -70° C: 70 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: 3-5 days


Reference Range
<38 AU/mL


Clinical Significance
Infliximab is a therapeutic monoclonal antibody with the ability to bind to tumor necrosis factor (TNF), an inflammatory cytokine, blocking its action. Infliximab is indicated for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis. It is immunogenic and a significant percentage of treated patients develop antibodies. In these patients, antibodies may be associated with lower trough levels of the drug. Results >38 AU/mL indicate the presence of anti-drug antibody.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.