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...

Descripción completa

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
_version_ 1784707856034955264
author Stumptner, Conny
Stadlbauer, Vanessa
O’Neil, Dominic
Gessner, André
Hiergeist, Andreas
Zatloukal, Kurt
Abuja, Peter M.
author_facet Stumptner, Conny
Stadlbauer, Vanessa
O’Neil, Dominic
Gessner, André
Hiergeist, Andreas
Zatloukal, Kurt
Abuja, Peter M.
author_sort Stumptner, Conny
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9104691
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-91046912022-05-14 The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit? Stumptner, Conny Stadlbauer, Vanessa O’Neil, Dominic Gessner, André Hiergeist, Andreas Zatloukal, Kurt Abuja, Peter M. Nutrients Concept Paper 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. MDPI 2022-05-09 /pmc/articles/PMC9104691/ /pubmed/35565946 http://dx.doi.org/10.3390/nu14091976 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Concept Paper
Stumptner, Conny
Stadlbauer, Vanessa
O’Neil, Dominic
Gessner, André
Hiergeist, Andreas
Zatloukal, Kurt
Abuja, Peter M.
The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title_full The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title_fullStr The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title_full_unstemmed The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title_short The Pre-Analytical CEN/TS Standard for Microbiome Diagnostics—How Can Research and Development Benefit?
title_sort pre-analytical cen/ts standard for microbiome diagnostics—how can research and development benefit?
topic Concept Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9104691/
https://www.ncbi.nlm.nih.gov/pubmed/35565946
http://dx.doi.org/10.3390/nu14091976
work_keys_str_mv AT stumptnerconny thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT stadlbauervanessa thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT oneildominic thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT gessnerandre thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT hiergeistandreas thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT zatloukalkurt thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT abujapeterm thepreanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT stumptnerconny preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT stadlbauervanessa preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT oneildominic preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT gessnerandre preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT hiergeistandreas preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT zatloukalkurt preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit
AT abujapeterm preanalyticalcentsstandardformicrobiomediagnosticshowcanresearchanddevelopmentbenefit

Ejemplares similares