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.
