Nucleic acid reference materials (NARMs): definitions and issues

Deborah A. Payne; Cyril D.S. Mamotte; David Gancberg; Mario Pazzagli; Ron H.N. van Schaik; Heinz Schimmel; Francois Rousseau; on behalf of the IFCC Committee for Molecular Diagnostics (C-MD)

doi:10.1515/CCLM.2010.313

Published by De Gruyter October 25, 2010

Nucleic acid reference materials (NARMs): definitions and issues

Deborah A. Payne , Cyril D.S. Mamotte , David Gancberg , Mario Pazzagli , Ron H.N. van Schaik , Heinz Schimmel , Francois Rousseau and on behalf of the IFCC Committee for Molecular Diagnostics (C-MD)

From the journal Clinical Chemistry and Laboratory Medicine

https://doi.org/10.1515/CCLM.2010.313

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Abstract

Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation of diagnostic methods and tests. Yet, 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 in the context of molecular diagnostics.

Clin Chem Lab Med 2010;48:1531–5.

Keywords: calibrator; control; DNA; genes; quality; quality assurance; reference materials; validation

Corresponding author: Deborah A. Payne, PhD, 6116 East Warren Avenue, Denver, CO 80227, USA Phone: +1-303-515-2217, Fax: +1-303-512-2288, dpayne@unipathllc.com

Published Online: 2010-10-25

Published in Print: 2010-11-01

Nucleic acid reference materials (NARMs): definitions and issues

Abstract

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