In house-Validierung mikrobiologischer Pruefverfahren

摘要

This paper describes the complete procedure for the in house (single laboratory) validation of microbiological methods. For this purpose the methods have to be classified on one hand in qualitative and quantitative, on the other hand in alternative and new. Some specific points and problems are illustrated and discussed on practical examples. A large simplification of the validation of quantitative methods can be achieved by applying 2 x 2 contingency tables and calculation of the concordance index kappa. The experimentally determination of the 95 % confidence inter-vall of a quantitative method yielded values in the order of 0.3 to 0.5 log_(10)-units. This is close to values used in international microbiological proficiency testing where z-score calculation is often based on a 95% confidence intervall of one log_(10)-unit.