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Ustekinumab Quantitation with Antibodies, Serum
Test Code39986
CPT Codes
80299, 83520
Preferred Specimen
0.5 mL serum
Minimum Volume
0.35 mL
Instructions
Collect immediately before the next dose of drug administration (trough level)
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 21 days
Frozen: 21 days
Refrigerated: 21 days
Frozen: 21 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Gross lipemia • Heat-inactivated specimen
Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)
FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Setup Schedule
Tuesday, Friday Morning
Report available: Next Day
Report available: Next Day
Reference Range
See Laboratory Report
Clinical Significance
-Evaluation of loss of response to therapy
-Quantification of ustekinumab in human serum
-Trough level quantitation for evaluation of patients treated with ustekinumab
-Detection of antibodies to ustekinumab in human serum
-Quantification of ustekinumab in human serum
-Trough level quantitation for evaluation of patients treated with ustekinumab
-Detection of antibodies to ustekinumab in human serum