CLSI EP12-A2 定性测试性能评估的用户协议.pdf

EP12-A2 Vol. 28 No. 3 Replaces EP12-A Vol. 22 No. 14 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition This document provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests. Guidance is provided for both precision and method-comparison studies. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. Licensed to: Jill Runyen Abbott This document is protected by copyright. CLSI order # Subscription, id # 468452, Downloaded on 2/18/2008. Clinical and Laboratory Standards Institute Advancing Quality in Health Care 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. health care community. It is reco