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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. 

This document is available in electronic format only.

This edition of the document was corrected in October 2021. Read the full correction notice here, and learn more about our corrections process here.

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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: print not available

Edition: Second

Pages: 64

EP12 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.