Assessment of detection methods in trace analysis by means of a statistically based in-house validation concept

A matrix-considering in-house validation concept for analytical methods is presented which takes into account the uncertainty due to matrix- and time-induced deviations. It is based on a variance component model for univariate quantitative measurement data that can be adapted to both screening and confirmation methods and to both zero-tolerance and threshold decisions. The model allows the calculation of critical concentrations for given α-errors and the calculation of the corresponding power function to evaluate the performance of an analytical method. The model is applied to a real-life validation experiment.