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User Protocol for Evaluation of Qualitative Test Performance

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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Chairholder: Patricia E. Garrett, PhD

Date of Publication: January 25, 2008

Order Code PDF: EP12A2E
ISBN Number: 1-56238-654-9

Order Code Print: EP12A2
ISBN Number: 1-56238-654-9

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.