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Full Description

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.

 

Document History

  1. CLSI EP12


    Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition, EP12Ed3E

    • Most Recent
  2. CLSI EP12-A2

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

    • Historical Version