In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination

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.

Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 2: Untersuchung von menschlicher RNA

Dieses Dokument legt Anforderungen und Empfehlungen für Arbeitsabläufe bei der Sequenzierung der nächsten Generation (NGS) für die In vitro-Diagnostik und biomedizinische Forschung fest. Dieses Dokument behandelt die präanalytischen Verfahren, die Isolierung humaner RNA, die Vorbereitung einer Sequenzierungsbibliothek, die Sequenzierung, die Sequenzanalyse und die Berichterstellung über die Untersuchung der Sequenzen für diagnostische Zwecke, ausgehend von isolierter RNA, z. B. aus formalinfixierten und paraffineingebetteten Geweben, aus frisch eingefrorenen Gewebeproben, Feinnadelaspiraten (FNAs), Vollblut, zirkulierenden Tumorzellen (CTCs), Exosomen und anderen extrazellulären Vesikeln sowie zirkulierender zellfreier RNA aus Plasma.
ANMERKUNG 1   Typische Anwendungen umfassen, ohne darauf beschränkt zu sein, NGS für die Onkologie und klinische Genetik sowie bestimmte Einzelzell-Analysen.
Dieses Dokument ist anwendbar für molekulare in vitro-diagnostische Untersuchungen, wozu auch im Labor entwickelte Prüfungen zählen, die von medizinischen Laboratorien, Laboratorien der molekularen Pathologie und molekulargenetischen Laboratorien durchgeführt werden. Dieses Dokument ist darüber hinaus auf Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika sowie auf Biobanken, Institutionen und Organisationen, die biomedizinische Forschungen durchführen, anwendbar.
Dieses Dokument ist nicht anwendbar für die In situ-Sequenzierung, forensische Sequenzierung, Sequenzierung von Pathogenen oder Mikroorganismen sowie die Mikrobiomanalyse.
ANMERKUNG 2   Internationale, nationale oder regionale Regelungen bzw. Anforderungen, oder mehrere von ihnen, können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Diagnostic in vitro Séquençage de nouvelle génération (NGS) - Partie 2 : Examens de l'ARN humain

No Scope Available

In vitro diagnostični delovni postopki Sekvenciranje naslednje generacije (NGS) - 2. del: Preiskava človeškega RNK

Ta dokument določa zahteve in podaja priporočila za in vitro diagnostične delovne postopke Sekvenciranje naslednje generacije (NGS) in biomedicinske raziskave. Ta dokument obravnava predpreiskovalne procese, izolacijo človeškega RNK, oblikovanje knjižnice sekvenciranja, sekvenciranje, analizo sekvenc in poročanje o preučitvi sekvenc za diagnostične namene iz izoliranega RNK iz npr. tkiv, ki so fiksirana v formalinu ter položena v parafin, sveže zamrznjenih tkiv, aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo (FNA), polne krvi, tumorskih celic v cirkulaciji (CTC), eksosomov in drugih zunajceličnih veziklov, iz plazme cirkulajoče brezcelične RNK.
OPOMBA 1: Tipične vrste uporabe vključujejo, vendar niso omejene na sekvenciranje naslednje generacije za onkologijo, klinično genetiko in določene enocelične analize.
Ta dokument se uporablja za molekularne in vitro diagnostične preiskave, vključno z laboratorijsko razvitimi preskusi, ki se izvajajo v medicinskih laboratorijih, laboratorijih za molekularno patologijo in laboratorijih za molekularno genetiko. Ta dokument se prav tako uporablja za laboratorijske stranke, razvijalce in proizvajalce diagnostike in vitro, biobanke, institucije in organizacije, ki izvajajo biomedicinske raziskave.
Ta dokument se ne uporablja za sekvenciranje in situ, forenzično sekvenciranje, sekvenciranje patogenov ali mikroorganizmov in analiziranje mikrobioma.
OPOMBA 2: Za določene teme, ki so zajete v tem dokumentu, se lahko uporabljajo tudi mednarodni, nacionalni ali regionalni predpisi oziroma zahteve.

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Standards Content (Sample)

SIST-TS CEN/TS 17981-2:2024
In vitro diagnostični delovni postopki Sekvenciranje naslednje generacije (NGS) -
2. del: Preiskava človeškega RNK
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA
Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 2:
Untersuchung von menschlicher RNA
Diagnostic in vitro Séquençage de nouvelle génération (NGS) - Partie 2 : Examens de
l'ARN humain
Ta slovenski standard je istoveten z: CEN/TS 17981-2:2023
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17981-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 17981-2:2024

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SIST-TS CEN/TS 17981-2:2024

CEN/TS 17981-2


November 2023
ICS 11.100.10
English Version

In vitro diagnostic Next Generation Sequencing (NGS)
workflows - Part 2: Human RNA examination
Diagnostic in vitro Séquençage de nouvelle génération Next Generation Sequencing (NGS)-Arbeitsabläufe für
(NGS) - Partie 2 : Examens de l'ARN humain die In-vitro-Diagnostik - Teil 2: Untersuchung von
menschlicher RNA
This Technical Specification (CEN/TS) was approved by CEN on 15 October 2023 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.



CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17981-2:2023 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 17981-2:2024
CEN/TS 17981-2:2023 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements . 20
4.1 General. 20
4.2 Examination design . 21
4.3 Examination development . 25
4.4 Examination performance verification and validation . 25
4.5 Technical examination performance characteristics . 30
5 Pre-examination processes for examination development . 31
5.1 General. 31
5.2 Human RNA isolation .

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