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.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Payne DA,Mamotte CD,Gancberg D,Pazzagli M,van Schaik RH,Schimmel H,Rousseau F,IFCC Committee for Molecular Diagnostics (C-MD).doi
10.1515/CCLM.2010.313subject
Has Abstractpub_date
2010-11-01 00:00:00pages
1531-5issue
11eissn
1434-6621issn
1437-4331journal_volume
48pub_type
杂志文章,评审abstract:BACKGROUND:There is a need for reference materials (RMs) in the field of genetic testing for verification of test results obtained in patients and probands. For the frequent genetic variation G20210A in the prothrombin gene, it has been shown that purified plasmids containing the gene fragment harbouring the mutation c...
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