Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Draft Guideline-Second Edition
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.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.
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Chairholder: Martin H. Kroll, MD
Date of Publication: November 30, 2011
Order Code PDF: EP24A2E
ISBN Number: 1-56238-778-2
Order Code Print: EP24A2
ISBN Number: 1-56238-777-4
EP24 Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.