CLSI EP17-A2 检出限和定量限的建立与验证.pdf

EP17-A2 Vol. 32 No. 8 Replaces EP17-A Vol. 24 No. 34 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition This document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. Licensed to Patty Wang. ANSI order X_294860. Downloaded 10/23/2012 11:09 PM. Single user license only. Copying and networking prohibited. Clinical and Laboratory Standards Institute Advancing Quality in Health Care Testing Clinical and Laboratory Standards Institute (CLSI) is an CLSI’s Administrative Procedures. It does not always international, interdisciplinary, nonprofit, standards connote unanimous agreement, but does mean that the developing, and educational organization that promotes the participants in the development of a consensus document development and use of voluntary consensus standards and have considered and resolved all relevant objections and guidelines within the health care community. We are are willing to accept the resulting agreement. CLSI recognized worldwide for the application of our