Journal
NUTRIENTS
Volume 14, Issue 9, Pages -Publisher
MDPI
DOI: 10.3390/nu14091976
Keywords
microbiome; diagnostics; European standard; in-vitro diagnostics; pre-analytics
Categories
Funding
- Joint Action European Joint Programming Initiative A Healthy Diet for a Healthy Life (JPI HDHL)
- Austrian Federal Ministry for Education, Science and Research
- Austrian consortium of the Knowledge Platform on Food, Diet, Intestinal Microbiomics and Human Health
- Austrian ministry [BMBWF-10.470/0010V/3c/2018]
- European Union's Horizon 2020 research and innovation programme [733112]
- Austrian Research Promotion Agency (Center for Biomarker Research in Medicine (CBmed), a COMET K1 center)
- Austrian Science Fund [FWF KLI 741]
- INTIMIC [01EA1906E]
- Deutsche Forschungsgemeinschaft (DFG)
- H2020 Societal Challenges Programme [733112] Funding Source: H2020 Societal Challenges Programme
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This article introduces the European pre-analytical standard for microbiome DNA analysis in human specimens and discusses the importance and advantages of standardization in biomedical research.
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.
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