Nucleic acid reference materials (NARMs): definitions and issues.
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.
Payne
Deborah A
DA
Molecular Services, American Pathology Partners-Unipath LLC, Denver, Colorado, USA. dpayne@unipathllc.com
Mamotte
Cyril D S
CD
Gancberg
David
D
Pazzagli
Mario
M
van Schaik
Ron H N
RH
Schimmel
Heinz
H
Rousseau
Francois
F
D006801:Humans; D007390:International Agencies; D009696:Nucleic Acids / Q000032:analysis* / Q000235:genetics; D057089:Pathology, Molecular / Q000592:standards*; D012015:Reference Standards; D017422:Sequence Analysis, DNA; D009626:Terminology as Topic
D009696:Nucleic Acids