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We compare 4 statistical models for the establishment of assigned values in a control serum which are based on the assumption of a normal distribution. The first model results in mean +/- 2s, whereas each of the following 3 models are based on a special analysis of variance. We studied by means of appropriate statistical tests the distributional properties of the data of the study described in part 1 of this series (Passing, H. et al. (1981) this j. 19, 1137-1144). Many model assumptions are violated: The totality of data of each method was never normally distributed, normal distribution within laboratories was not given in 27 out of 67 cases, and precision and accuracy varied from reference laboratory to reference laboratory. Moreover, assigned values and uncertainty intervals calculated by means of these methods can be misleading to the customer. Therefore, these models cannot be applied, and a distribution-free procedure has to be used instead.

clinical chemistry and laboratory medicine

The Inadequacy of Normal Distribution Models for the Establishment of Assigned Values in Control Sera.  The Establishment of Assigned Values in Control Sera, II.