EP12
User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition
This document provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests. Guidance is provided for both precision and method-comparison studies.
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Publication Details
Chairholder: Patricia E. Garrett, PhD
Date of Publication: January 25, 2008
ISBN Number: 1-56238-654-9
Order Code PDF: EP12A2E
Order Code Print: print not available
Edition: Second
Pages: 64
EP12 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.