CLSI EP09-A2
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Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, EP09-A2
Clinical and Laboratory Standards Institute , 09/20/2002
Pages: 56
CLSI EP09-A2 addresses procedures for determining the bias between two clinical methods or devices, and for the design of a method comparison experiment using split patient samples and data analysis.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guidleine for use in satisfying a regulatory requirement.
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