Validation of quantitative analytical procedures in laboratory medicine/Validierung von quantitativen Analysenverfahren in der Laboratoriumsmedizin

AbstractThe validation of analytical procedures in laboratory medicine has been discussed by many authors and several recommendations have been elaborated by working groups and standardization bodies. However, some problems have not sufficiently been solved, for example, permissible limits for the comparability between methods (permissible equivalence), what is the best statistical procedure for estimating the function of the fitting line in scatter plots, and permissible limits for the spread around the fitting line. The present article attempts to summarize the present state-of-the-art and to provide answers to some of the open problems.