CEN/TS 16826-3:2018
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
This document gives recommendations for the handling, storage, processing and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 3: Isolierte DNA
Dieses Dokument gibt Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von aus gefrorenem Gewebe bestehendem und für die DNA-Untersuchung vorgesehenem Untersuchungsmaterial während der präanalytischen Phase vor Beginn der molekularen Untersuchung.
Dieses Dokument ist anwendbar auf molekulare in-vitro-diagnostische Untersuchungen, einschließlich im Laboratorium entwickelter Prüfungen, die von medizinischen Laboratorien und Laboratorien der molekularen Pathologie durchgeführt werden, die aus gefrorenem Gewebe isolierte DNA auswerten. Es ist außerdem dafür vorgesehen, von Kunden des Laboratoriums, Entwicklern und Herstellern von In-vitro-Diagnostika sowie Biobanken, Einrichtungen und kommerziellen Organisationen, die biomedi-zinische Forschungen durchführen, und Aufsichtsbehörden angewendet zu werden.
Gewebe, die vor dem Gefriervorgang einer chemischen Vorbehandlung zur Stabilisierung unterzogen wurden, sind nicht durch dieses Dokument abgedeckt.
ANMERKUNG Internationale, nationale oder regionale Bestimmungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za hitro zamrznjena tkiva - 3. del: Izolirani DNA
Ta dokument podaja priporočila za obravnavo, shranjevanje, obdelavo in dokumentiranje vzorcev zamrznjenih tkiv, namenjenih za analizo DNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi testi, ki jih izvajajo medicinski laboratoriji in laboratoriji za molekularno patologijo, ki ocenjujejo DNK, izoliran iz zamrznjenega tkiva. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, in regulativni organi.
Tkiva, ki so pred zamrzovanjem prestala predobdelavo za kemično stabilizacijo, niso zajeta v tem dokumentu.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DKLWUR]DPU]QMHQDWNLYDGHO ,]ROLUDQL'1$
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for snap frozen tissue - Part 3: Isolated DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 1: Isolierte DNA
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé
Ta slovenski standard je istoveten z: CEN/TS 16826-3:2018
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TS 16826-3
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
July 2018
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for snap frozen tissue - Part
3: Isolated DNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren
relatives aux processus préanalytiques pour les tissus à - Spezifikationen für präanalytische Prozesse für
congélation rapide - Partie 3: ADN isolé schockgefrorene Gewebeproben - Teil 3: Isolierte DNA
This Technical Specification (CEN/TS) was approved by CEN on 16 April 2018 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16826-3:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General considerations . 9
5 Outside the laboratory . 9
5.1 Specimen collection . 9
5.1.1 General . 9
5.1.2 Information about the specimen donor/patient . 9
5.1.3 Information about the specimen . 10
5.1.4 Specimen processing . 10
5.2 Fresh tissue transport requirements. 11
5.2.1 General . 11
5.2.2 Preparations for the transport . 11
5.2.3 During transport . 11
6 Inside the laboratory . 11
6.1 Information about the reception of the specimen . 11
6.2 Evaluation of the pathology of the specimen and selection of the sample(s) . 12
6.3 Freezing of the specimen or sample(s) . 13
6.4 Storage requirements . 15
6.5 DNA isolation . 15
6.5.1 General . 15
6.5.2 Using commercial kits . 16
6.5.3 Using the laboratory's own protocols . 16
6.6 Quantity and quality assessment of isolated DNA . 16
6.7 Storage of isolated DNA . 17
Bibliography . 18
European foreword
This document (CEN/TS 16826-3:2018) has been prepared by 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.
CEN/TS 16826 consists of the following parts:
— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap
frozen tissue — Part 1: Isolated RNA;
— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap
frozen tissue — Part 2: Isolated proteins;
— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap
frozen tissue — Part 3: Isolated DNA.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Introduction
Molecular in vitro diagnostics, including molecular pathology, has enabled a significant progress in
medicine. Further progress is expected with new technologies analysing nucleic acids, proteins, and
metabolites in human tissues and body fluids. However, integrity of these molecules can change during
specimen collection, transport, storage, and processing, thus making the outcome from diagnostics or
research unreliable or even impossible because the subsequent examination assay will not determine
the situation in the patient but an artificial pattern generated during the pre-examination process.
Therefore, a standardization of the entire process from specimen collection to the DNA examination is
needed. Studies have been undertaken to determine the important influencing factors. This document
draws upon such work to codify and standardize the steps for frozen tissue with regard to DNA
examination in what is referred to as the pre-examination phase.
DNA integrity in tissues can change during processing and storage. Modifications of the DNA molecules
can impact the validity and reliability of the examination test results. Therefore, it is essential to take
special measures to minimize the described DNA changes and modifications for subsequent
examination.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
1 Scope
This document gives recommendations for the handling, storage, processing and documentation of
frozen tissue specimens intended for DNA examination during the pre-examination phase before a
molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory
developed tests performed by medical laboratories and molecular pathology laboratories that evaluate
DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in
this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics
covered in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 15189:2012, Medical laboratories — Requirements for quality and competence (ISO 15189:2012,
Corrected version 2014-08-15)
EN ISO/IEC 17020:2012, Conformity assessment — Requirements for the operation of various types of
bodies performing inspection (ISO/IEC 17020:2012)
ISO 15190, Medical laboratories — Requirements for safety
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 15189 and the following
apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
aliquot
portion of a larger amount of homogenous material, assumed to be taken with negligible sampling error
Note 1 to entry: The term is usually applied to fluids. Tissues are heterogeneous and therefore cannot be
aliquoted.
Note 2 to entry: The definition is derived from the Compendium of Chemical Terminology Gold Book.
International Union of Pure and Applied Chemistry. Version 2.3.3., 2014; the PAC, 1990,62,1193 (Nomenclature
for sampling in analytical chemistry (Recommendations 1990)) p. 1206; and the PAC 1990, 62, 2167 (Glossary of
atmospheric chemistry terms (Recommendations 1990)) p. 2173.
3.2
ambient temperature
unregulated temperature of the surrounding air
3.3
analyte
component represented in the name of a measurable quantity
[SOURCE: EN ISO 17511:2003, 3.2, modified — The example was not taken over.]
3.4
analytical test performance
accuracy, precision, and sensitivity of a test to measure the analyte of interest
Note 1 to entry: Other test performance characteristics such as robustness, repeatability can apply as well.
3.5
cold ischemia
condition after removal of the tissue from the body until its stabilization or fixation
3.6
diagnosis
identification of a health or disease state from its signs and/or symptoms, where the diagnostic process
can involve examinations and tests for classification of an individual's condition into separate and
distinct categories or subclasses that allow medical decisions about treatment and prognosis to be
made
3.7
DNA
deoxyribonucleic acid
polymer of deoxyribonucleotides occurring in a double-stranded (dsDNA) or single-stranded (ssDNA)
form
[SOURCE: EN ISO 22174:2005, 3.1.2]
3.8
DNase
deoxyribonuclease
enzyme that catalyzes the degradation of DNA into smaller components
3.9
examination
analytical test
set of operations having the object of determining the value or characteristics of
...
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