CEN ISO/TS 7552-2:2024
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024)
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2.
This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben - Teil 2: Isolierte DNA (ISO/TS 7552‑2:2024)
Dieses Dokument legt Anforderungen fest und gibt Empfehlungen zur Handhabung, Lagerung, CTC Anreicherung und Isolierung, RNA Isolierung und Lagerung sowie Dokumentation venösem Vollblut-Untersuchungsmaterial, das für die Untersuchung der aus zirkulierenden Tumorzellen (CTC) isolierten DNA vorgesehen ist, während der präanalytischen Phase vor der Durchführung einer molekularen Analyse.
Dieses Dokument ist anwendbar auf molekulare in vitro-diagnostische Untersuchungen, die in medizinischen Laboratorien durchgeführt werden, einschließlich vom Laboratorium selbst entwickelter Verfahren. Es ist darüber hinaus für die Verwendung durch Kunden von Laboratorien, Entwickler und Hersteller von In-vitro-Diagnostika, durch Biobanken, Institutionen und kommerzielle Organisationen, die biomedizinische Forschung betreiben, sowie durch Arzneimittelagenturen bestimmt.
Dieses Dokument behandelt nicht die direkte Isolierung von genomischer DNA aus venösen Vollblutproben, die CTC enthalten. Diese wird in ISO 20186 2 behandelt.
Dieses Dokument behandelt nicht die Isolierung von bestimmten weißen Blutzellen (Leukozyten) und die anschließende Isolierung von genomischer DNA aus diesen Zellen oder die Anforderungen an den präanalytischen Arbeitsablauf zur Kryokonservierung und Kultivierung lebensfähiger CTC.
ANMERKUNG 1 Die in diesem Dokument dargelegten Anforderungen können auch auf andere zirkulierende Zellen (z. B. fetale Zellen) angewendet werden.
ANMERKUNG 2 Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTC) dans le sang total veineux - Partie 2: ADN isolé (ISO/TS 7552-2:2024)
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 2. del: Izolirana DNK (ISO/TS 7552-2:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2025
Nadomešča:
SIST-TS CEN/TS 17390-2:2020
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 2. del: Izolirana
DNK (ISO/TS 7552-2:2024)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS
7552-2:2024)
Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in
venösen Vollblutproben - Teil 2: Isolierte DNA (ISO/TS 7552-2:2024)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les cellules tumorales circulantes (CTC) dans le sang total veineux -
Partie 2: ADN isolé (ISO/TS 7552-2:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 7552-2:2024
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 7552-2
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
November 2024
TECHNISCHE SPEZIFIKATION
ICS 11.100.10 Supersedes CEN/TS 17390-2:2020
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for circulating tumour cells
(CTCs) in venous whole blood - Part 2: Isolated DNA
(ISO/TS 7552-2:2024)
Analyses de diagnostic moléculaire in vitro - Spezifikationen für präanalytische Prozesse für
Spécifications relatives aux processus préanalytiques zirkulierende Tumorzellen (CTC) in venösen
pour les cellules tumorales circulantes (CTC) dans le Vollblutproben - Teil 2: Isolierte DNA (ISO/TS 7552-
sang total veineux - Partie 2: ADN isolé (ISO/TS 7552- 2:2024)
2:2024)
This Technical Specification (CEN/TS) was approved by CEN on 10 November 2024 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 7552-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 7552-2:2024) has been prepared by Technical Committee ISO/TC 212
"Medical laboratories and in vitro diagnostic systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TS 17390-2:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to announce this Technical Specification: 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 the
United Kingdom.
Endorsement notice
The text of ISO/TS 7552-2:2024 has been approved by CEN as CEN ISO/TS 7552-2:2024 without any
modification.
Technical
Specification
ISO/TS 7552-2
First edition
Molecular in vitro diagnostic
2024-11
examinations — Specifications
for pre-examination processes for
circulating tumour cells (CTCs) in
venous whole blood —
Part 2:
Isolated DNA
Analyses de diagnostic moléculaire in vitro — Spécifications
relatives aux processus préanalytiques pour les cellules tumorales
circulantes (CTC) dans le sang total veineux —
Partie 2: ADN isolé
Reference number
ISO/TS 7552-2:2024(en) © ISO 2024
ISO/TS 7552-2:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Published in Switzerland
ii
ISO/TS 7552-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations . 5
5 Activities outside the laboratory. 6
5.1 Specimen collection .6
5.1.1 General .6
5.1.2 Information about the patient/specimen donor .6
5.1.3 Selection of the venous whole blood collection tube by the laboratory .6
5.1.4 Venous whole blood specimen collection from the patient/donor .7
5.2 Specimen storage and transport .7
5.2.1 General .7
5.2.2 Storage and transport using blood collection tubes with stabilizers .8
5.2.3 Storage and transport using blood collection tubes without stabilizers .8
6 Activities inside the laboratory . 8
6.1 Specimen reception .8
6.2 Specimen storage after transport and reception .9
6.3 Enrichment of CTCs .9
6.3.1 General .9
6.3.2 Using a commercial CTC enrichment system intended for diagnostic use .9
6.3.3 Using the laboratory developed CTC enrichment procedure .10
6.4 Quality of enriched CTCs .10
6.5 Storage of enriched CTCs .10
6.6 Isolation of CTCs .11
6.6.1 General .11
6.6.2 Using a commercial CTC isolation system intended for diagnostic use .11
6.6.3 Using the laboratory-developed CTC isolation procedure .11
6.7 Isolation of DNA from an enriched CTC sample .11
6.7.1 General .11
6.7.2 Using a commercial DNA isolation kit intended for diagnostic use . 12
6.7.3 Using a laboratory-developed CTC DNA isolation procedure . 12
6.8 Quantity and quality assessment of isolated DNA from enriched or isolated CTCs . 13
6.8.1 General . 13
6.8.2 Quantity assessment of CTC DNA . 13
6.8.3 Quality assessment of CTC DNA . 13
6.9 Storage of isolated DNA from enriched CTCs . 13
6.9.1 General . 13
6.9.2 Storage of DNA isolated with a commercially available kit intended for
diagnostic use .14
6.9.3 Storage of DNA isolated with the laboratory developed procedure .14
Annex A (informative) Decision guideline for critical steps of the CTC pre-analytical workflow .15
Bibliography . 17
iii
ISO/TS 7552-2:2024(en)
Foreword
ISO (the International Organizat
...
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