Analyses of the pattern of therapeutic drug monitoring in a university hospital laboratory. Suitability and performance of the CEDIA assays

Abstract

New homogeneous enzyme immunoassays (CEDIA assays) for therapeutic drug monitoring were evaluated on Boehringer Mannheim/Hitachi 704. A fluorescence polarization immunoassay and HPLC were chosen as comparison methods. A good correlation of patient data was observed for both methods (slopes 1.033-1.167). Imprecision within-run and between-day as well as the recovery in control samples of an external quality control survey were excellent and comparable to the routine method. In order to optimize the use of the CEDIA assays also for parameters which are less frequently requested, a parameter-setting for the batch-analyzer COBAS Fara was worked out. Performance of the CEDIA assays on random access analyzers is discussed with regard to the background of a laboratory for clinical chemistry in a University Hospital.