CLSI EP10-A3 临床实验室定量测量程序的初步评价 第3版.pdf

EP10-A3 Vol. 26 No. 34 Replaces EP10-A2 Vol. 22 No. 29 Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition This guideline provides experimental design and data analysis for preliminary evaluation of the performance of a measurement procedure or device. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. Clinical and Laboratory Standards Institute Advancing Quality in Healthcare Testing The Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus— formerly NCCLS) is an international, interdisciplinary, “proposed” and “approved.” Depending on the need for nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be organization that promotes the development and use of made available for review at an intermediate consensus voluntary consensus standards and guidelines within the level. healthcare community. It is recognized worldwide for the Proposed A consensus document undergoes the first stage application of its unique consensus process in the