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The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.

Each Procise IFX assay kit includes Procise IFX reagent cartridges, buffer bulbs, and Procise IFX low and high assay controls as follows: - Twenty pouched Procise IFX cartridges each containing a lyophilized test-specific reagent bead contains a dry reagent bead located in the cartridge cap comprised of < 50 ug of test-specific conjugates (monoclonal Fab anti-IFX/TNFa complex labeled with acceptor fluorophore and TNFa labeled with donor fluorophore) - Twenty 1.5mL buffer bulbs . - Two pouched assay IFX Low controls - Two pouched assay IFX High controls . - Product Insert - Quick Reference Guide . The Procise IFX assay requires the ProciseDx Analyzer. The ProciseDx Analyzer is designed to detect time-resolved fluorescent signal from both the donor and FRET acceptor emission within the Procise IFX assay.