The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics-How Can Research and Development Benefit?

Stumptner, Conny and Stadlbauer, Vanessa and O'Neil, Dominic and Gessner, Andre and Hiergeist, Andreas and Zatloukal, Kurt and Abuja, Peter M. (2022) The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics-How Can Research and Development Benefit? NUTRIENTS, 14 (9): 1976. ISSN , 2072-6643

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Abstract

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.

Item Type: Article
Uncontrolled Keywords: SAMPLES; ERRORS; IMPACT; DNA; microbiome; diagnostics; European standard; in-vitro diagnostics; pre-analytics
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Depositing User: Dr. Gernot Deinzer
Date Deposited: 29 Feb 2024 16:03
Last Modified: 29 Feb 2024 16:03
URI: https://pred.uni-regensburg.de/id/eprint/58484

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