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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
Specimen Volume	2 mL serum (0.5 mL min)
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 Laboratories	Prometheus Therapeutics & Diagnostics
CPT	80299 82542- Ab
PDM	2059731 , 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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