EP14-A2 Evaluation of Matrix Effects; Approved Guideline—Second Edition

Clinical and Laboratory Standards Institute (CLSI) document EP14-A2—Evaluation of Matrix Effects; Approved Guideline— Second Edition was developed for manufacturers, regulators, and providers of proficiency testing or external quality assessment programs, although it will be useful to clinical laboratories as well. The document will help users to determine whether matrix effects are the source of unexpected results that are sometimes observed with processed samples when two measurement procedures are compared; to identify and quantify the magnitude of the effects; and to ensure that laboratory performance is evaluated fairly if matrix effects are present. The suggested protocols were developed using patient specimens as the standard of comparison. A list of definitions is included. Clinical and Laboratory Standards Institute. Evaluation of Matrix Effects; Approved Guideline—Second Edition. Clinical and Laboratory Standards Institute document EP14-A2 (ISBN 1-56238-561-5). 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 by the healthcare 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in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of Clinical and Laboratory Standards Institute documents. Current editions are listed in the Clinical and Laboratory Standards Institute Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the Clinical and Laboratory Standards Institute Catalog, contact the Clinical and Laboratory Standards Institute Executive Offices. Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org