Historical
CLSI GP10-A
Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
Provides guidance for laboratorians who assess clinical test accuracy. It is not a recipe; rather it is a set of concepts to be used to design an assessment of test performance or to interpret data generated by others. In addition to the use of ROC plots, the importance of defining the question, selecting a sample group, and determining the "true" clinical state are emphasized. The statistical data generated can be useful whether one is considering replacing an existing test, adding a new test, or eliminating a current test. FDA
Clinical And Laboratory Standards Institute [clsi]