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

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 labora...

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Detalles Bibliográficos
Autores principales: Stumptner, Conny, Stadlbauer, Vanessa, O’Neil, Dominic, Gessner, André, Hiergeist, Andreas, Zatloukal, Kurt, Abuja, Peter M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Concept Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9104691/
https://www.ncbi.nlm.nih.gov/pubmed/35565946
http://dx.doi.org/10.3390/nu14091976
Descripción
Sumario: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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