Title: Nucleic Acid Reference Materials (NARMs): Definitions and Issues
Authors: PAYNE DeborahMAMOTTE CyrilGANCBERG DavidPAZZAGLI MarioVAN SCHAIK RonSCHIMMEL HeinzROUSSEAU F.
Citation: CLINICAL CHEMISTRY AND LABORATORY MEDICINE vol. 48 no. 11 p. 1531-1535
Publisher: WALTER DE GRUYTER & CO
Publication Year: 2010
JRC N°: JRC59426
ISSN: 1434-6621
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC59426
DOI: 10.1515/CCLM.2010.313
Type: Articles in Journals
Abstract: Ground breaking advances have occurred in the development and application of molecular diagnostic techniques in all the disciplines encompassed by laboratory medicine. Nevertheless there are many concerns relating to the use of molecular diagnostics within clinical settings, such as the paucity of analytical and clinical performance standards, external quality control programs, reference methods and reference materials; As in other areas of laboratory medicine, reference materials are important for the development, validation, and interpretation of diagnostic methods and tests. However there is a lack of harmonization between the numerous international organizations currently either certifying or defining reference materials. The objective of this position paper is to review and clarify the definition, attributes and applications for the use of reference materials the context of molecular diagnostics.
JRC Institute:Institute for Reference Materials and Measurements

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