title: An innovative approach to functionality testing of analysers in the clinical laboratory.
abstract: The established protocols for evaluating new analytical systems produce indispensable information with regard to quality characteristics, but in general they fail to analyse the system performance under routine-like conditions. We describe a model which allows the testing of a new analytical system under conditions close to the routine in a controlled and systematic manner by using an appropriate software tool. Performing routine simulation experiments, either reflecting imprecision or method comparison characteristics, gives the user essential information on the overall system performance under real intended-use conditions.
authors.affiliation: Roche Diagnostics GmbH, Professional Diagnostics, Clinical Trials, 68305 Mannheim, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Stockmann
authors.forename: Werner
authors.initials: W
authors.lastname: Engeldinger
authors.forename: Albert
authors.initials: A
authors.lastname: Kunst
authors.forename: Margaret
authors.initials: M
authors.lastname: McGovern