CLSI EP7-A2：2005 - Interference Testing in Clinical Chemistry.pdfVIP

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CLSI EP7-A2：2005 - Interference Testing in Clinical Chemistry.pdf

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EP7-A2 ISBN 1-56238-584-4 Volume 25 Number 27 ISSN 0273-3099 Interference Testing in Clinical Chemistry; Approved Guideline— Second Edition Robert J. McEnroe, PhD Mary F. Burritt, PhD Donald M. Powers, PhD Douglas W. Rheinheimer, MT Brian H. Wallace, PhD Abstract Clinical and Laboratory Standards Institute document EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition is intended to promote uniformity in the evaluation of interference characteristics of clinical laboratory measurement procedures. EP7 describes procedures for manufacturers to screen potentially interfering substances, to quantify interference effects, and to confirm interference in patient samples. This document also describes procedures for clinical laboratories to verify interference claims, and to investigate discrepant results caused by unsuspected interfering substances. Detailed examples are given. EP7 also contains background information on interference testing concepts, tables of recommended test concentrations for analytes and potential interference, and data collection and analysis worksheets. Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition . CLSI document EP7-A2 (ISBN 1-56238-584-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005. The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review