National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD 20899-8312, USA.
Expert Rev Mol Diagn. 2011 Sep;11(7):741-55. doi: 10.1586/erm.11.50.
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.
在传染病和临床遗传学的核酸检测中，非常需要协调一致。检测方法的多样化、分子诊断的目标数量以及标准参考物质的缺乏，导致实验室之间的检测结果存在差异。本文全面介绍了参考物质、相关文件标准和能力验证计划。本文探讨了这些资源之间的关系，并为该领域的从业人员提供了正式课程中未教授且经常临时获取的必要信息。本文的目的是为分子诊断实验室提供有用的工具。
