Diagnostic and Research Center for Molecular Biomedicine, Institute of Pathology, Medical University of Graz, 8010 Graz, Austria.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, 8010 Graz, Austria.
Nutrients. 2022 May 9;14(9):1976. doi: 10.3390/nu14091976.
Recently, CEN/TS 17626:2021, the European pre-analytical standard for human specimens intended for microbiome DNA analysis, was published. Although this standard relates to diagnostic procedures for microbiome analysis and is relevant for in vitro diagnostic (IVD) manufacturers and diagnostic laboratories, it also has implications for research and development (R&D). We present here why standards are needed in biomedical research, what pre-analytical standards can accomplish, and which elements of the pre-analytical workflow they cover. The benefits of standardization for the generation of FAIR (findable, accessible, interoperable, reusable) data and to support innovation are briefly discussed.
最近，欧洲用于人类微生物组 DNA 分析标本的预分析标准 CEN/TS 17626:2021 发布了。虽然该标准与微生物组分析的诊断程序有关，与体外诊断 (IVD) 制造商和诊断实验室相关，但它也对研究和开发 (R&D) 具有影响。我们在此介绍为什么在生物医学研究中需要标准，预分析标准可以完成什么，以及它们涵盖了预分析工作流程的哪些要素。标准化对生成 FAIR（可发现、可访问、可互操作、可重用）数据以及支持创新的好处也进行了简要讨论。
