Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE™ UST

Test Code

USTEKAB

Quest Code

38319

Alias/See Also

Anti-interleukin antibody drug, Anti-IL12, IL23 inhibitor
Biologic monitoring, therapeutic drug monitoring (TDM)
Immunogenicity testing, anti-drug antibody
Stelara
504594 (LabCorps TC)
804594

CPT Codes
80299, 82397<br /> Limited Access Code

Preferred Specimen

3 mL serum

Minimum Volume

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

Other Acceptable Specimens

serum collected in a red-top tube or gel-barrier 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, please submit separate frozen specimens for each test requested.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days

Methodology
Electrochemiluminescence (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

Set up: Wed; Report available: 8-11 days

Reference Range

Ustekinumab drug level:	<0.1 ug/mL
Anti-ustekinumab antibody:	<40 ng/mL

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.

Performing Laboratory
Esoterix Endocrinology
4301 Lost Hills Road
Calabasas Hills, CA 91301

Last Updated: July 12, 2023

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.