CLSI Publishes Guideline for Evaluation of Qualitative Test Performance.WAYNE, Pa. -- Qualitative diagnostic tests have been used since the early days of laboratory medicine for the screening, diagnosis, and management of a variety of diseases. Method evaluation procedures for such tests are diverse, with each laboratory specialty often emphasizing different issues in both the experimental design and in the data analysis and interpretation of such studies. Clinical and Laboratory Standards Institute (CLSI CLSI Clinical and Laboratory Standards Institute (Wayne, PA) CLSI Cisco Link Services Interface , formerly NCCLS NCCLS National Committee for Clinical Laboratory Standards ) recently published an updated document, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline--Second Edition (EP12-A2), to provide guidance for performing uniform, well-defined studies that can be used to adequately evaluate and describe performance characteristics of qualitative tests. This document, addressing both precision and method-comparison studies, is a revision of EP12-A, and includes the following updates: * confidence limits achieved by different numbers of observations made and different results observed; * new terms See suggestions for new terms. included and defined; * a figure to illustrate which error sources the protocol can detect with respect to all error sources and other CLSI Evaluation Protocols documents; and * an appendix that describes and discusses the confidence intervals confidence interval, n a statistical device used to determine the range within which an acceptable datum would fall. Confidence intervals are usually expressed in percentages, typically 95% or 99%. used in the protocol. The intended users of the guideline guideline Medtalk A series of recommendations by a body of experts in a particular discipline. See Cancer screening guidelines, Cardiac profile guidelines, Gatekeeper guidelines, Harvard guidelines, Transfusion guidelines. include: laboratories of all types that perform qualitative tests; manufacturers of qualitative diagnostic tests, for describing test performance and helping customers design test performance verification studies; and regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. and laboratory surveyors. For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100. CLSI, formerly NCCLS, is a global, nonprofit A corporation or an association that conducts business for the benefit of the general public without shareholders and without a profit motive. Nonprofits are also called not-for-profit corporations. Nonprofit corporations are created according to state law. , membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion