[New approaches to electronic data processing in clinical evaluation of coagulation diagnosis]

The present paper describes several possibilities of electronic data processing (EDP) in clinical evaluation of new diagnostic reagents for coagulation. In order to evaluate two novel assays for determination of prothrombin time (PT) new statistical and graphical methods were developed and tested for their practicability. These methods are especially useful for establishing reference curves, for checking the characteristics of new PT reagents, for determining the "International Sensitivity Index" of each lot of reagents and of the specific therapeutic range for oral anticoagulation as well as for testing the comparability with other PT reagents. The results show that the statistical and graphical methods have proved their usefulness for clinical evaluation of new PT methods and that there might be further applications for such methods in comparison tests of similar coagulation assays.