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CLSI EP09-A2

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition

NCCLS document EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition, is written for laboratorians as well as manufacturers. It describes procedures for determining the relative bias between two methods, and it identifies factors to be considered when designing and analyzing a method-comparison experiment using split patient samples. For carrying out method-comparison evaluations, an overview of the experiment, sample data recording and calculation sheets, and an overview flowchart and a detailed flowchart for preliminary data examination are included. As an additional aid, a sample scatter plot and bias plot are introduced for those who are unfamiliar with these procedures. The final section contains recommendations for manufacturers' evaluation of bias and statement format for bias claims.


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Clinical And Laboratory Standards Institute [CLSI]


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