CLSI EP12-A2 PDF
CLSI EP12-A2 PDF
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CLSI EP12-A2 PDF

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User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, Second Edition, EP122A

Published byPublication DateNumber of Pages
CLSI01/01/200864

CLSI EP12-A2 – User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, Second Edition, EP122A

This document contains a protocol that optimizes the experimental design for the evaluation of qualitative tests, to better measure performance and provide a structured data analysis.

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

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