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User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline

EP12-A provides the user with a consistent approach for protocol design and data analysis when evaluating qualitative diagnostics tests. Guidance is provided for both reproducibility and method-comparison studies. FDA

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User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline

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EP12-A

User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline

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