INFLIXIMAB ANTIBODY

Test Code

LAB3953

Quest Code

36301

CPT Codes
82397

Preferred Specimen

0.6 mL serum

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

0.4 mL

Transport Container

Transport tube

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

Mon, Tues, Thurs-Sat

Report Available

1-3 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.

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

Last Updated: August 31, 2021

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.