Title EP12Ed3E_sma.pdf ✅

EP12 Evaluation of Qualitative, Binary Output Examination Performance This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. 3rd Edition
Clinical and Laboratory Standards Institute Setting the standard for quality in medical 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 medical 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 development of all CLSI documents. It does not always connote unanimous agreement but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and accept the resulting agreement. Commenting on Documents CLSI documents undergo periodic evaluation and modification to keep pace with advances in technologies, procedures, methods, and protocols affecting the laboratory or health care. CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process. At the end of each comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate. Comments on published CLSI documents are equally essential and may be submitted by anyone, at any time, on any document. All comments are managed according to the consensus process by a committee of experts. Appeal Process When it is believed that an objection has not been adequately considered and responded to, the process for appeal, documented in the CLSI Standards Development Policies and Processes, is followed. All comments and responses submitted on draft and published documents are retained on file at CLSI and are available upon request. Get Involved—Volunteer! Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get involved in the revision process? Or maybe you see a need to develop a new document for an emerging technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents to improve the standards that affect your own work, you will play an active role in improving public health across the globe. For additional information on committee participation or to submit comments, contact CLSI. Clinical and Laboratory Standards Institute P: +1.610.688.0100 F: +1.610.688.0700 www.clsi.org [email protected]
The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If you or your organization is not a member and would like to become one, or to request a copy of the catalog, contact us at: P: +1.610.688.0100 F: +1.610.688.0700 E: [email protected] W: www.clsi.org EP12-Ed3 March 2023 Replaces EP12-A2 Evaluation of Qualitative, Binary Output Examination Performance Jeffrey R. Budd, PhD Karl De Vore, BA, SSBB Ralf C. Bollhagen, PhD Abdel-Baset Halim, PharmD, PhD, DABCC Paul S. Horn, PhD Marina V. Kondratovich, PhD Qin Li, PhD Kristen Meier, PhD Gene Pennello, PhD Diane M. Ward, PhD Abstract Clinical and Laboratory Standards Institute guideline EP12—Evaluation of Qualitative, Binary Output Examination Performance describes the categories of qualitative, binary output examinations and covers their performance evaluations for imprecision, including estimating C5 and C95, clinical performance (sensitivity and specificity), and stability and interferences. Clinical and Laboratory Standards Institute (CLSI). Evaluation of Qualitative, Binary Output Examination Performance. 3rd ed. CLSI guideline EP12 (ISBN 978-1-68440-176-5 [Print]; ISBN 978-1-68440-177-2 [Electronic]). Clinical and Laboratory Standards Institute, USA, 2023.