EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Clinical and Laboratory Standards Institute document EP09-A3—Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition 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 split 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 section contains recommendations for manufacturers’ evaluation of bias and statement format for bias claims. Clinical and Laboratory Standards Institute (CLSI). Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition. CLSI document EP09-A3 (ISBN 1-56238-887-8 [Print]; ISBN 1-56238-888-6 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2013. The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org.