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The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients. The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use. The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm. The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay. The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays.

The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme ()-galactosidase, which has been genetically engineered into two inactive fragments termed enzyme donor (ED) and enzyme acceptor (EA). These fragments spontaneously re-associate to form fully active enzymes that, in assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically. The assay consists of a set of four reagents: Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent. A two-level (Low and High) set of calibrators is used to calibrate the assay. A three-level set of controls (1 through 3) is used for quality control of the assay.