an innovative approach to functionality testing of analysers in the clinical laboratory一个创新的方法来分析仪器在临床实验室的功能测试.pdfVIP
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an innovative approach to functionality testing of analysers in the clinical laboratory一个创新的方法来分析仪器在临床实验室的功能测试
Hindawi Publishing Corporation
Journal of Automated Methods and Management in Chemistry
Volume 2008, Article ID 183747, 6 pages
doi:10.1155/2008/183747
Research Article
An Innovative Approach to Functionality Testing of
Analysers in the Clinical Laboratory
Wolfgang Stockmann, Werner Engeldinger, Albert Kunst, and Margaret McGovern
Roche Diagnostics GmbH, Professional Diagnostics, Clinical Trials, 68305 Mannheim, Germany
Correspondence should be addressed to Wolfgang Stockmann, wolfgang.stockmann@
Received 12 November 2007; Accepted 19 December 2007
Recommended by Peter B. Stockwell
The established protocols for evaluating new analytical systems produce indispensable information with regard to quality char-
acteristics, 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.
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.
1. INTRODUCTION 2. METHODS
Conventionally, the evaluation of new analytical systems is We have integrated this functionality in our evaluation soft-
conducted on the basis of established protocols related to an- ware tool Windows-based computer-aided evaluation
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