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Test Code PUSTSO Anser UST, Prometheus (Ustekinumab) (3190)

Important Note

For internal ordering only. Not available to outreach clients. Test is available to MMC-Dickinson.

Additional Codes

Prometheus Test Code: 3190

Useful For

To measure and monitor serum ustekinumab (UST) and antibodies-to-ustekinumab (ATU) levels at any time during therapy.

 

***Test is NOT available for Outreach clients, (but is available to MMC - Dickinson).***

Synonyms/Keywords

Stelara

Specimen Requirements

Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
 
Serum Serum Separator Tube (SST) Red Top Tube (RTT) 2.0 mL    

Collection/Processing Instructions

Send ambient or cold pack. Do not freeze.

Specimen Stability Information

Specimen Type Temperature Time
 

Serum

 
Ambient 14 days
Refrigerated 14 days

Rejection Criteria

Frozen Specimens

Whole Blood

Test Information

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

Performing Laboratory Name

Prometheus Labs

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #
 
9410 Carroll Park Drive
San Diego, CA 92121
888-423-5227 https://prometheuslabs.com 1299

Performing Information

Performing Location Analytical Time
Prometheus Laboratories 3 days

 

CPT Codes

CPT Modifier
(if needed)
Quantity Description Comments
 
80299
 
1 Serum ustekinumab (UST) concentration
 
82542
 
1 Antibody to ustekinumab (ATU) concentration  

Ordering Applications

Ordering Application Description
 
Cerner Anser UST, Prometheus (Ustekinumab) (3190)