Nucleic Acid Reference Materials (NARMs): Definitions and Issues

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.

PAYNE Deborah;  MAMOTTE Cyril;  GANCBERG David;  PAZZAGLI Mario;  VAN SCHAIK Ron;  SCHIMMEL Heinz;  ROUSSEAU F.; 

2010-11-30

WALTER DE GRUYTER & CO

JRC59426

1434-6621,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC59426,   

10.1515/CCLM.2010.313,