Performance profiles: new tools for characterization and comparison of clinical chemical results.

It is current practice to record the performance of immunoassays by means of precision profiles (according to Ekins), in which the variation coefficient (relative standard deviation) is plotted against the analyte concentration. On the other hand, precision profiles are only occasionally used for evaluating the performance of conventional clinical-chemical methods. It is relatively uncommon to find bias plotted against analyte concentration, presumably because this type of analysis requires reference specimens, whose true analyte concentrations are known or guaranteed by reference methods. If the relative systematic variations are plotted against the true analyte concentrations, and a confidence interval is added to the resulting regression curve, the result is a "bias profile"; if tolerance limits are added, the result is a "deviation profile". The present work describes the preparation of specimens, which can be used to provide experimental data for the three performance profiles. A computer program is used to construct the precision profile, bias profile and/or deviation profile. The mathematical-statistical basis of the program is described in detail. For evaluation of the statistical procedure, three analytes and six methods were used: determination of sodium activity/concentration with an ion sensitive electrode and by flame photometry; determination of creatinine by a manual enzymic and a mechanized Jaffé method; determination of thyrotropin by radioimmunoassay and by luminescence immunoassay. Different purposes are served by bias and deviation profiles. Thus, bias profiles can be used to compare the bias of two methods, whereas a deviation profile can be used to define the analytical range of a method. If the acceptable limits of deviation are added to the deviation profile, then the useful analytical range of the method is immediately apparent.