PROMETHEUS Anser UST ANSERUST

Synonyms

Ustekinumab

Allscripts (AEHR) Order Name

Prometheus Anser UST

Sunrise Clinical Manager (SCM) Order Name

PROMETHEUS Anser UST

EPIC Order Name

PROMETHEUS Anser UST

Clinical Info

Simultaneously measures ustekinumab (UST) and antibodies to ustekinumab (UST) levels in serum at any time during therapy.
 
Quantify whether inflammatory bowel disease patients have antibodies and/or sufficient drug concentrations Measure antibodies in the presence of drugs (i.e., drug tolerant assay) Overcome many of the limitations of solid-phase assays Assay-specific drug and antibody levels correlated with clinical outcomes

Specimen Type

Blood

Container

Gold Top Tube

Collection Instructions

Container/Tube:   Gold top tube
Specimen: 2 mL serum (0.5 mL min)
Transport Temperature: 7 Days  Room Temperature 
                                          9 Days  Refrigerated

Transport Instructions

7 Days  Room Temperature

Specimen Stability

Methodology

Electrochemiluminescence Immunoassay (ECLIA)
 
Test Includes:  Ustekinumab (UST) and antibodies-to-ustekinumab (ATU) levels

Days Performed

Monday - Friday
  TAT = 4 days

Performing Laboratory

Prometheus Therapeutics & Diagnostics

CPT

80299
82542- Ab

PDM

2059731

Result Interpretation

       Assay                                                      Lower Limit of Quantification
Serum ustekinumab concentration (UST)           < 1.6 ug/mL
Antibodies to ustekinumab (ATU)                        < 1.6 U/mL
 
These tests have not been cleared or approved by the US FDA. The tests are used for clinical purposes and should not be regarded as investigational or for research. Prometheus Biosciences is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing and is accredited by the College of American Pathologists (CAP).
 

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