***Test is NOT available for Outreach clients, (but is available to MMC - Dickinson).***
Stelara
To measure and monitor serum ustekinumab (UST) and antibodies-to-ustekinumab (ATU) levels at any time during therapy.
Send ambient or cold pack. Do not freeze.
Frozen Specimens
Whole Blood
This test was developed and its performance characteristics determined by Prometheus Laboratories, CAP-accredited (6805501) and CLIA-certified (05D0917432) as qualified to perform high complexity testing. It has not been cleared or approved by the US Food and Drug Administration
The Anser® UST test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum ustekinumab (UST) and antibodies-to-ustekinumab (ATU) levels at any time during therapy.
Serum concentrations of ustekinumab (UST) may vary among equally dosed patients which can ultimately affect patient outcomes. Suboptimal levels of UST have been linked to lower response rates in IBD patients. Furthermore, some patients may develop immunogenicity to UST by producing ATU. The presence of ATU has also been associated with increased rates of infusion reactions and drug clearance leading to lower response rates. Therefore, the quantitative measurement of UST and ATU levels in serum provides valuable information to healthcare providers to better assess a patient's risk or reason for losing response to UST and helps them decide an appropriate course of action.
Serum ustekinumab (UST) Lower Limit of Quantification: < 0.9 ug/mL
Antibody to ustekinumab (ATU) Lower Limit of Quantification: < 1.6 U/mL