Ustekinumab Quantitation with Antibodies, Serum

Test Code

QUQAS

Quest Code

39986

CPT Codes
80299, 83520<br>Restricted Client Code<br><strong>This test is for New York patient testing only. For non-New York patient testing see test code 18217.</strong>

Preferred Specimen

0.5 mL serum

Minimum Volume

0.35 mL

Instructions

Collect immediately before the next dose of drug administration (trough level)

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 • Gross lipemia • Heat-inactivated specimen

Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)

FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

Setup Schedule

Set up: Tues, Fri; Report available: 1-4 days

Reference Range

See Laboratory Report

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 Clinic Laboratories
200 First Street SW
Rochester, MN 55905

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.