The CEDIA Phenobarbital assay has been evaluated in twelve clinical laboratories in Europe and U.S.A. on Boehringer Mannheim/Hitachi analysis systems. The evaluation focused on the analysis of imprecision and accuracy. Within-run and between-day coefficients of variations of the new assay were comparable to those of established routine methods. As demonstrated in an interlaboratory survey study with controls and human sera, results obtained in different laboratories showed a good agreement. The CEDIA Phenobarbital assay measured very accurately, as particularly confirmed by comparison with HPLC. It can be recommended as a reliable and practicable test for monitoring of phenobarbital on Boehringer Mannheim/Hitachi analyzers used in routine clinical chemistry.
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Ther Drug Monit
August 1993
Department of Clinical Chemistry, Psychiatric Hospital Veldwijk, Ermelo, The Netherlands.
We report the evaluation of the cloned enzyme donor immunoassay (CEDIA) for the estimation of phenytoin and phenobarbital in serum. The assays were performed with a Hitachi 911 analyzer. Intra-assay coefficients of variation were from 1.
View Article and Find Full Text PDFJ Immunol Methods
June 1992
Boehringer Mannheim GmbH, Werk Tutzing, Germany.
CEDIA assays represent a state of the art technique utilizing two genetically engineered, enzymatically inactive fragments of beta-galactosidase as the basis for a homogeneous enzyme immunoassay. The smaller, amino-terminal polypeptide, designated the enzyme donor (ED), can recombine spontaneously with the large residual fragment, called the enzyme acceptor (EA), to form active beta-galactosidase, in a process called complementation. ED have been designed in such a way that a ligand, such as a hormone or drug, can be chemically attached to a specific amino acid residue without affecting the enzyme complementation.
View Article and Find Full Text PDFWien Klin Wochenschr Suppl
September 1992
Microgenics Corporation, Conford, California.
New homogeneous enzyme immunoassays have been developed for cortisol, digoxin, digitoxin, theophylline, phenytoin, and phenobarbital using the cloned enzyme donor immunoassay technology. As applied to Boehringer Mannheim/Hitachi analysis systems these methods provide rapid, accurate and precise quantification of analytes, with minimal interferences from endogenous serum constituents and low cross-reactivities to structurally-related hormonal precursors, drug metabolites and natural compounds. Additional significant features of the new assays are linear standard curves and two-point calibration.
View Article and Find Full Text PDFWien Klin Wochenschr Suppl
September 1992
Boehringer Mannheim GmbH, Federal Republic of Germany.
The CEDIA Phenobarbital assay has been evaluated in twelve clinical laboratories in Europe and U.S.A.
View Article and Find Full Text PDFWien Klin Wochenschr Suppl
September 1992
Institut für Klinische Chemie, Klinikum Mannheim, Federal Republic of Germany.
Sera from the routine of therapeutic drug monitoring were assayed for phenobarbital, phenytoin, and theophylline with three different methods: fluorescence polarization immunoassay as the standard procedure, the new CEDIA assays within a multicenter evaluation and HPLC which is known to yield results with a high specificity. CVs for between-day imprecision ranged from 2.6-8.
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