In Vitro Diagnostics: CEDIA® Mycophenolic Acid (MPA) Assay

The Thermo Scientific™ CEDIA® Mycophenolic Acid (MPA) 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 MPA Assay uses recombinant DNA technology to produce a unique homogenous enzyme immunoassay system. The assay is based on the enzyme β-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.