Infliximab Level and Anti-drug Antibody

Test Code

38299

CPT Codes
80299, 83520<br>Limited Access Code

Preferred Specimen

2 mL serum collected in a red-top tube (no gel)

Patient Preparation
For up to 48 hours before blood draw, do not take multivitamins or dietary supplements containing biotin or vitamin B7.

Minimum Volume

0.5 mL

Instructions

The blood should be drawn just before the next infusion of Infliximab to measure the trough drug level.
Shipping room temperature unacceptable; Shipping frozen acceptable.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 48 hours
Refrigerated: 7 days
Frozen -20°C: 28 days
Frozen -70°C: 70 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Serum separator tube (SST) • Grossly icteric

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 the U.S. Food and Drug Administration. 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

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.