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Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing
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DOI：10.1586/ERM.11.50.png)
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Abstract
En 中文
There is a great need for harmonization in nucleic acid testing for infectious disease and clinical genetics. The proliferation of assay methods, the number of targets for molecular diagnostics and the absence of standard reference materials contribute to variability in test results among laboratories. This article provides a comprehensive overview of reference materials, related documentary standards and proficiency testing programs. The article explores the relationships among these resources and provides necessary information for people practicing in this area that is not taught in formal courses and frequently is obtained on an ad hoc basis. The aim of this article is to provide helpful tools for molecular diagnostic laboratories.
Keywords:
DNA
documentary standards
external quality assessment
genetic testing
infectious disease diagnostics
molecular methods
NAT
nucleic acid testing
proficiency testing
reference material
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