Application of statistical procedures in analytical instrument testing

Evaluation of analytical instruments in clinical laboratories should be carried out in a systematic and uniform manner in order to provide data which can be compared and reproduced by different users, manufacturers and officials. Concepts for such an evaluation of instruments with continuous measurement values are presented in the ECCLS guidelines [1]. To quantify the results of an investigation, the data has to be condensed by the use of statistical methods. Obviously the design of an experiment and the statistical model used for evaluating the data are closely related. Only if the distributional structure of the experimental data is understood will it be possible to obtain an unbiased interpretation of the statistical results.