Therapeutic Drug Monitoring :
CEDIA Mycophenolic Assay for the
BECKMAN COULTER AU480/AU680/AU5800 Clinical Chemistry Systems
The Thermo ScientificTM 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.
In the assay, analyte in the specimen competes with analyte conjugated to ED of β-galactosidase for limited numbers of antibody binding sites. If analyte is present in the sample, it binds to the antibody leaving the ED conjugate free to form active enzymes with the EA. If analyte is not present in the sample, the antibody binds to analyte conjugated to ED, Inhibiting the re-association of ED to EA, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
Feature s of the Mycophenolic Acid Assay
› Ready-to-Use liquid calibrators
› 2-Point calibration
› EDTA plasma sample type
› Low-End sensitivity (LDD = 0.07 μg/mL)
› Reportable range (0.3 – 10 μg/mL)