title: Clinical evaluation of five therapeutic drugs using dry film multilayer technology on the OPUS immunoassay system.
abstract: Five therapeutic drug assays, carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid, were evaluated using an automated random access system for performing thin dry film multilayer competitive immunoassays, the OPUS analyzer. All reagents for the therapeutic drug assays are contained in a coated multilayer film chip encased within a plastic bar-coded test module and require no external or supplementary reagents. A serum or plasma sample is applied to the test module by the instrument and the fluorescence intensity from the module is measured after 6 minutes. We found the OPUS assays acceptable for clinical use. Within-run coefficient of variations were 2.3-6.7%, between-run, 2.9-7.6%. These methods correlated well with the Abbott TDx, having correlation coefficients of 0.92-0.97. Because of the instrument design and the stability of the reagents, weekly calibration is not needed and samples can be run immediately upon receipt in a random access fashion or can be batched together.
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL 60153.
authors.forename: M A
authors.initials: MA
authors.lastname: Jandreski
authors.forename: J C
authors.initials: JC
authors.lastname: Shah
authors.forename: J
authors.initials: J
authors.lastname: Garbincius
authors.forename: E W
authors.initials: EW
authors.lastname: Bermes
mesh_terms: D002220:Carbamazepine / Q000097:blood; D005069:Evaluation Studies as Topic; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D010634:Phenobarbital / Q000097:blood; D010672:Phenytoin / Q000097:blood; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013806:Theophylline / Q000097:blood; D014635:Valproic Acid / Q000097:blood
chemical_list: D004364:Pharmaceutical Preparations; D002220:Carbamazepine; D014635:Valproic Acid; D010672:Phenytoin; D013806:Theophylline; D010634:Phenobarbital