CLSI EP09

Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition

Laboratorians and IVD manufacturers can learn about bias between two measurement procedures, and identifying factors for consideration when designing and analyzing a measurement procedure with EP09.

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This edition of the document was corrected in June 2018. Read the full correction notice here, and learn more about our corrections process here.

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Chairholder: Jeffrey R. Budd, PhD

Date of Publication: June 20, 2018

Order Code PDF: CLSI EP09Ed3cE
ISBN Number: 978-1-68440-007-2

Order Code Print: print not available

Edition: Third

Pages: 116

CLSI EP09 Additional Details

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EP09 was corrected in June 2018, and the code was revised to EP09c.

CLSI EP09 Abstract

Clinical and Laboratory Standards Institute guideline EP09—Measurement Procedure Comparison and Bias Estimation Using Patient Samples is written for laboratorians and manufacturers. It describes procedures for determining the bias between two measurement procedures, and it identifies factors for consideration when designing and analyzing a measurement procedure comparison experiment using patient samples. An overview of the measurement procedure comparison experiment includes considerations for both manufacturers and laboratorians. Details on how to create difference and scatter plots for visual inspection of the data are provided. Once the data are characterized, various methods are introduced for quantifying the relationship between two measurement procedures, including bias estimates and regression techniques. The final chapter contains recommendations for manufacturers’ evaluation of bias and statement format for bias claims.