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CEN/TS 16827-3:2015

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations [1], changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles [2]. These modifications of the DNA molecules can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA analysis.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für FFPE-Gewebeproben - Teil 3: Isolierte DNS

Diese Technische Spezifikation gibt Empfehlungen zur Handhabung, Dokumentation und Verarbeitung von aus FFPE Gewebe bestehendem und für die DNS Analyse vorgesehenem Untersuchungsmaterial während der präanalytischen Phase vor Beginn der molekularen Analyse. Diese Technische Spezifikation gilt für molekulare in vitro diagnostische Untersuchungen (z. B. In vitro Diagnostik Labore, Kunden dieser Labore, Entwickler und Hersteller von In vitro Diagnostika, Einrichtungen und kommerzielle Organisationen, die in der biomedizinischen Forschung tätig sind, Biobanken und Aufsichtsbehörden).
Die DNS Integrität in Geweben kann sich vor und nach der Formalinfixierung, der Verarbeitung und der Lagerung verändern. Während der Gewebefixierung in die DNS eingebrachte chemische Modifikationen können zu Fragmentierungen und Sequenzänderungen [1], Veränderung des Methylierungszustands oder sogar zu Struktur¬veränderungen führen, die z. B. störende Kopienanzahlveränderungen in Array CGH Profilen bewirken können [2]. Diese Modifikationen der DNS Moleküle können die Gültigkeit und Zuverlässigkeit der analytischen Prüfergebnisse beeinträchtigen. Daher ist es wichtig, dass besondere Maßnahmen getroffen werden, um die beschriebenen Modifikationen im Hinblick auf die anschließende DNS Analyse möglichst gering zu halten.

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus FFPE - Partie 3: ADN isolé

La présente Spécification technique fournit des recommandations pour la manipulation, la documentation et le traitement des spécimens de tissus FFPE destinés à l’analyse de l’ADN durant la phase préanalytique précédant la réalisation d’un essai moléculaire. La présente Spécification technique s’applique aux examens de diagnostic moléculaire in vitro (par exemple, laboratoires de diagnostic in vitro, clients de laboratoires, concepteurs et fabricants de diagnostic in vitro, institutions et organisations commerciales de recherche biomédicale, biobanques et autorités réglementaires).
L’intégrité de l’ADN dans les tissus peut changer avant et pendant la fixation au formol, le traitement et le stockage. Les modifications chimiques apportées à l’ADN durant la fixation des tissus peuvent causer une fragmentation et une altération des séquences [1], des changements de l’état de méthylation ou même des changements structuraux susceptibles de conduire, par exemple, à des modifications erronées du nombre de copies dans les profils d’hybridation génomique comparative sur puce à ADN [2]. Ces modifications des molécules d’ADN peuvent avoir une incidence sur la validité et la fiabilité des résultats d’essais analytiques. Il est donc essentiel de prendre des mesures spéciales afin de réduire le plus possible les modifications décrites lors de l'analyse subséquente de l’ADN.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za FFPE tkiva - 3. del: Izolirani DNK

Ta tehnična specifikacija vsebuje priporočila za obravnavo, dokumentiranje in obdelavo vzorcev tkiv FFPE, namenjenih za analizo DNK med predanalizno fazo, preden se izvede molekularni preskus. Ta tehnična specifikacija se uporablja za molekularne diagnostične preiskave in vitro (npr. diagnostični laboratoriji in vitro, laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativni organi).
Integriteta DNK v tkivih se lahko spremeni pred fiksacijo v formalinu, obdelavo in shranjevanjem ter med temi postopki. Kemijske spremembe DNK med fiksacijo tkiva lahko pripeljejo do sprememb zaporedja [1], sprememb v stanju metilacije ali celo strukturnih sprememb, kar lahko vodi do npr. sprememb števila napačnih kopij pri molekularni kariotipizaciji aCGH [2]. Te spremembe molekul DNK lahko vplivajo na veljavnost in zanesljivost rezultatov analitičnih preskusov. Zato je treba sprejeti posebne ukrepe za zmanjšanje opisanih sprememb pri nadaljnjih analizah DNK.

General Information

Status
Withdrawn
Publication Date
11-Aug-2015
Withdrawal Date
22-Jan-2019
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
23-Jan-2019
Ref Project
SIST-TS CEN/TS 16827-3:2015 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA

Relations

Replaced By
EN ISO 20166-3:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
Effective Date
05-Sep-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 16827-3:2015
01-oktober-2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]D))3(WNLYDGHO,]ROLUDQL'1.
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for FFPE tissue - Part 3: Isolated DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für FFPE-Gewebe - Teil 3: Isolierte DNS
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus FFPE - Partie 3: ADN
Ta slovenski standard je istoveten z: CEN/TS 16827-3:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16827-3:2015 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 16827-3:2015

---------------------- Page: 2 ----------------------

SIST-TS CEN/TS 16827-3:2015

TECHNICAL SPECIFICATION
CEN/TS 16827-3

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
August 2015
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications for
pre-examination processes for FFPE tissue - Part 3: Isolated
DNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren -
relatives aux processus préanalytiques pour les tissus Spezifikationen für präanalytische Prozesse für FFPE-
FFPE - Partie 3: ADN isolé Gewebeproben - Teil 3: Isolierte DNS
This Technical Specification (CEN/TS) was approved by CEN on 6 July 2015 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16827-3:2015 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 16827-3:2015
CEN/TS 16827-3:2015 (E)
Contents Page
European foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 General considerations .7
5 Outside the laboratory .7
5.1 Primary tissue collection manual.7
5.1.1 Information about the primary sample donor .7
5.1.2 Information on the primary tissue sample .8
5.1.3 Information on the primary tissue sample processing .8
5.2 Transport requirements .
...

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