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Journal of Automated Methods and Management in Chemistry
Volume 2008, Article ID 183747, 6 pages
http://dx.doi.org/10.1155/2008/183747
Research Article

An Innovative Approach to Functionality Testing of Analysers in the Clinical Laboratory

Roche Diagnostics GmbH, Professional Diagnostics, Clinical Trials, Mannheim 68305, Germany

Received 12 November 2007; Accepted 19 December 2007

Academic Editor: Peter B. Stockwell

Copyright © 2008 Wolfgang Stockmann et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.