Therapeutic Drug Monitoring :
CEDIA CYCLOSPORINE PLUS (LOW RANGE:CSAL & HIGH RANGE: CSAH)
for the BECKMAN COULTER AU480/AU680/AU5800 Clinical Chemistry Systems
The Thermo ScientificTM CEDIA® Cyclosporine PLUS assay is for the in vitro quantitative determination of cyclosporine in human whole blood using automated clinical chemistry analyzers as an aid in the management of cyclosporine therapy in kidney, liver, and heart transplants.
The CEDIA Cyclosporine PLUS assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully-active enzymes that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzymes. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
FEATURES OF THE CYCLOSPORINE ASSAY INCLUDE
› Ready-to-Use liquid calibrators
› 2-Point calibration
› Low-End sensitivity (Low Range: LDD=0.04 ng/mL)
› Reportable range (Low Range: 25 – 450 ng/mL;
High Range: 450 – 2000 ng/mL)
› Reproducibility across assay range