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EP24

Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves, 2nd 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.

This document is available in electronic format only.

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Publication Details

Chairholder: Martin H. Kroll, MD

Date of Publication: November 30, 2011

ISBN Number: 1-56238-777-4

Order Code PDF: EP24A2E

Order Code Print: print not available

Edition: Second

Pages: 56

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.