Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA

This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3.
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 Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA

Dieses Dokument legt Anforderungen fest an und gibt Empfehlungen für die Handhabung, Lagerung, Verarbeitung und Dokumentation von für die Untersuchung von humaner cfDNA vorgesehenen Körperflüssigkeitenproben 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. Es ist darüber hinaus für die Verwendung durch Gesundheitseinrichtungen, einschließlich Einrichtungen, die Primärproben entnehmen und handhaben, Laborkunden, Entwickler und Hersteller von In vitro-Diagnostika, Biobanken, in der biomedizinischen Forschung tätige Einrichtungen und kommerzielle Organisationen sowie Aufsichtsbehörden, vorgesehen.
Spezielle Maßnahmen, die bei der zytohistologischen Analyse von aus Körperflüssigkeiten entnommenen kernhaltigen Zellen erforderlich sind, werden in dieser Technischen Spezifikation nicht beschrieben. Des Weiteren werden auch keine Maßnahmen zur Konservierung und Handhabung von Pathogen- und sonstiger bakterieller oder Mikrobiom-DNA in Körperflüssigkeiten beschrieben.
Für die Konservierung von ccfDNA aus anderen Körperflüssigkeiten wie Blut, Lymphe u. a. müssen abweichende spezielle Maßnahmen getroffen werden. Diese werden nicht in diesem Dokument beschrieben. ccfDNA aus Blut ist Gegenstand von EN ISO 20186-3.
ANMERKUNG   Für bestimmte Aspekte, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK

Ta dokument določa zahteve ter podaja priporočila glede obravnave, shranjevanja, obdelave in dokumentiranja vzorcev telesnih tekočin, namenjenih za preiskave cirkulirajoče brezcelične DNK (cfDNA) med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, ki jih izvajajo v medicinskih laboratorijih. Uporabljale naj bi ga tudi zdravstvene ustanove, vključno z ustanovami, ki zbirajo in obravnavajo vzorce, laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi.
V tej tehnični specifikaciji niso opisani namenski ukrepi za citohistološko analizo celic z jedri, pridobljenih iz telesnih tekočin. Prav tako niso opisani ukrepi za ohranjanje in ravnanje s patogeni ter drugo bakterijsko ali mikrobiomsko DNK v telesnih tekočinah.
Za ohranjanje cirkulirajoče brezcelične DNK iz drugih telesnih tekočin, kot so kri, limfa in ostale tekočine, je treba uporabiti drugačne namenske ukrepe. Slednji niso opisani v tem dokumentu. Cirkulirajoča brezcelična DNK iz krvi je obravnavana v standardu EN ISO 20186 3.
OPOMBA:   Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Publication Date
21-Jun-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
22-Jun-2022
Due Date
01-Dec-2020
Completion Date
22-Jun-2022

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SLOVENSKI STANDARD
01-september-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for urine and other body fluids - Isolated cell free DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA
Ta slovenski standard je istoveten z: CEN/TS 17811:2022
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/TS 17811
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
June 2022
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for urine and other body
fluids - Isolated cell free DNA
Molekularanalytische in-vitro-diagnostische Verfahren
- Spezifikationen für präanalytische Prozesse für Urin
und andere Körperflüssigkeiten - Isolierte zellfreie
DNA
This Technical Specification (CEN/TS) was approved by CEN on 17 May 2022 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, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17811:2022 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 requirements . 10
5 Outside the laboratory . 11
5.1 Specimen collection . 11
5.1.1 Information about the patient or specimen donor . 11
5.1.2 Selection of the body fluid collection device by the laboratory . 12
5.1.3 Body fluid specimen collection from the patient/donor and stabilization procedures. 12
5.1.4 Information about the specimen storage requirements at the body fluid collection
facility/site . 14
5.2 Transport requirements. 15
5.2.1 General . 15
5.2.2 Transport using body fluid collection devices with cfDNA stabilizers . 15
5.2.3 Transport using body fluid collection devices without cfDNA stabilizers . 15
6 Inside the laboratory . 16
6.1 General . 16
6.2 Specimen reception . 16
6.3 Specimen storage after transport and reception . 16
6.4 Body fluid specimen/sample processing prior to cfDNA isolation . 16
6.5 Storage requirements for body fluid samples after processing . 17
6.6 Isolation of body fluid cfDNA . 17
6.6.1 General . 17
6.6.2 Using commercial kit . 18
6.6.3 Using a laboratory developed isolation procedure . 18
6.7 Quantity and quality assessment of isolated cfDNA . 19
6.7.1 General . 19
6.7.2 Quantity assessment of cfDNA . 19
6.7.3 Quality assessment of cfDNA . 19
6.8 Storage of isolated body fluid cfDNA . 20
6.8.1 General . 20
6.8.2 Storage of isolated body fluid cfDNA, isolated with a commercially available kit . 20
6.8.3 Storage of isolated body fluid cfDNA, isolated with the laboratory's own procedure . 21
Bibliography . 22
European foreword
This document (CEN/TS 17811:2022) 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
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 implement this European Standard: 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, Turkey and the United
Kingdom.
Introduction
Molecular in vitro diagnostics has enabled a significant progress in medicine. Further progress is expected
by new technologies analysing profiles of nucleic acids, proteins, and metabolites in human tissues and
body fluids. However, the profiles of these molecules can change drastically during specimen collection,
transport, storage and processing thus making the outcome from diagnostics or research unreliable or
even impossible because the subsequent analytical assay will not determine the situation in the patient
but an artificial profile generated during the pre-examination process.
Most of the DNA in the body is located within cells, but a small amount of nucleic acids can also be found
outside of cells, so called cell-free DNA (cfDNA). In case of circulating body fluids such as blood, this DNA
is called circulating cell-free DNA (ccfDNA) and in case of non-circulating body fluids such as urine, saliva,
cerebrospinal fluid, pleural effusion, ascites, and synovial fluid, the DNA is called cell-free DNA (cfDNA).
cfDNA is of specific interest, as for example cfDNA in urine originates from cells from the genitourinary
tract or from ccfDNA in circulation passing through glomerular filtration [1]. cfDNA from cancerous or
malignant cells in urine have been associated with cancer specific sequences, epigenetic and structural
changes [2], [3].
Standardization of the entire workflow from specimen collection to the cfDNA examination is needed to
minimize release of DNA from cells into the fluid, and degradation of cfDNA in the specimen, which can
change the original native cfDNA profile in the body fluid after specimen collection. Post collection
microbial growth in the specimen can further enhance the degradation of the cfDNA, e.g. in urine and
saliva. Studies have been undertaken to determine the important influencing factors as they can impact
the sensitivity and reliability of cfDNA examination from urine and other body fluids.
This document draws upon such work to codify and standardize the steps for cfDNA examination from
body fluids in what is referred to as the pre-examination phase.
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 specifies requirements and gives recommendations on the handling, storage, processing
and documentation of body fluids specimens intended for human cfDNA examination during the pre-
examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical
laboratories. It is also intended to be used by health institutions including facilities collecting and
handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks,
institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated
cells are not described in this technical specification. Neither are measures for preserving and handling
of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as
blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in
EN ISO 20186-3.
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, Medical laboratories - Requirements for quality and competence (ISO 15189)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 15189 and the following
terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
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 [4], [5] and [6].
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 17511:2021, 3.1 — Deleted example.]
3.4
analytical test performance
analytical performance
examination performance
accuracy, precision, and sensitiv
...

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