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  • BSI
    PD CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Human RNA examination
    Edition: 2023
    $526.05
    / user per year

Description of PD CEN/TS 17981-2:2023 2023

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organisations performing biomedical research. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

Standard NumberPD CEN/TS 17981-2:2023
TitleIn vitro diagnostic Next Generation Sequencing (NGS) workflows - Human RNA examination
StatusDefinitive
Publication Date2023-12-04
Identical National Standard OfCEN/TS 17981-2:2023
DescriptorsHumans, Human body, Body (human), Sequencing, Testing, Diagnostic testing, RNA
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 21304 1
PublisherBSI
Pages68

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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