EP09-A3 用临床样本进行方法学比对和偏倚评估 (Measurement Procedure Comparision and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition)(2013).PDF

August 2013 EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition This document is for exclusive use by the CLSI StatisPro licencee only. Not for distribution. Steven li, KHB, Product key: SP-Z7DV-YRC8-XXXX-XXXX This document addresses the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. Clinical and Laboratory Standards Institute Setting the standard for quality in clinical laboratory testing around the world. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. Consensus Process Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the S T t h e i development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the v s