This document provides a protocol for evaluating the accuracy of a test to discriminate between two subclasses of subjects when there is some clinically relevant reason to separate them. In addition to the use of receiver operating characteristic curves and the comparison of two curves, the document emphasizes the importance of defining the question, selecting the sample group, and determining the ‘true’ clinical state.
CLSI EP24-A2 (R2018)
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Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition, EP24A2E
Clinical and Laboratory Standards Institute , 11/30/2011
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