Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE™ UST

Test Code
38319


CPT Codes
80299, 83520

Preferred Specimen
3 mL serum


Minimum Volume
1 mL
Note: This volume does not allow for repeat testing.


Other Acceptable Specimens
Plasma collected in: EDTA (lavender-top) tube • Sodium heparin (royal blue-top) tube


Instructions
Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Transport Temperature
Frozen


Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days


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


Methodology
Electrochemiluminescence Immunoassay (ECLIA)

FDA Status
These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.

Setup Schedule
Sets up 1 day a week.


Clinical Significance
Provides ustekinumab drug concentration and anti-ustekinumab antibodies in order to optimize treatment and facilitate clinical decision-making. This assay may be helpful in any patients on ustekinumab therapy for Crohn's disease, psoriasis, or other autoimmune conditions.




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.