Quality specifications based on analysis of effects of performance on clinical decision-making

The graphical model for evaluation of analytical requirements for bimodal distributions, based on probit transformation and calculation of false-positive and false-negative results for assumed random and systematic analytical errors, is presented in theory. It is concluded that the bimodal model is an excellent tool for evaluation of the effect of analytical quality and, therefore, useful for estimation of analytical quality specifications for quantities used in specific clinical strategies and situations as well as based on analysis of clinical outcome.