USTEKINUMAB LEVEL W/ABS

Test Code
LAB3923


Quest Code
39986


CPT Codes
80299, 83520

Preferred Specimen
0.5 mL serum


Patient Preparation
Collect immediately before next scheduled dose (trough specimen)

Minimum Volume
0.35 mL


Instructions
Collect immediately before next scheduled dose (trough specimen)


Transport Container
Transport tube


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: Unacceptable
Refrigerated: 21 days
Frozen: 21 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Heat-inactivated specimen


Methodology
Enzyme Linked Immunosorbent Assay (ELISA)

FDA Status
This test was developed and its performance characteristics have been determined by Mayo Clinic Laboratories. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Tues, Fri


Clinical Significance
Evaluation of loss of response to therapy.
Quantification of ustekinumab in human serum.
Trough level quantitation for evaluation of patients treated with ustekinumab.
Detection of antibodies to ustekinumab in human serum.


Performing Laboratory
Mayo Clinical Laboratories
3050 Superior Drive NW
Rochester, MN 55901



Last Updated: February 8, 2022


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.