oSIST prEN ISO 18704:2024

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024)

This document specifies requirements and provides recommendations for the pre-examination phase of cell free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, cerebrospinal fluid (CSF), pleural effusions and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen cleaning and isolation of cfDNA.
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 document. 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 circulating cell free DNA (ccfDNA) from blood. These are not described in this document, but are covered in 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 (ISO/DIS 18704:2024)

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour l’urine et d’autres liquides corporels - ADN libre extrait (ISO/DIS 18704:2024)

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK (ISO/DIS 18704:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Dec-2024
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 07-Nov-2024
• Due Date: 27-Mar-2025
• Ref Project: prEN ISO 18704 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024)

Relations

• Revises: SIST-TS CEN/TS 17811:2022 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
• Effective Date: 01-Feb-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2024
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK
(ISO/DIS 18704:2024)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA
(ISO/DIS 18704:2024)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour l’urine et d’autres liquides corporels - ADN libre extrait (ISO/DIS
18704:2024)
Ta slovenski standard je istoveten z: prEN ISO 18704
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.

DRAFT
International
Standard
ISO/DIS 18704
ISO/TC 212
Molecular in vitro diagnostic
Secretariat: ANSI
examinations — Specifications
Voting begins on:
for pre-examination processes
2024-10-23
for urine and other body fluids —
Voting terminates on:
Isolated cell free DNA
2025-01-15
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 18704:2024(en)
DRAFT
ISO/DIS 18704:2024(en)
International
Standard
ISO/DIS 18704
ISO/TC 212
Molecular in vitro diagnostic
Secretariat: ANSI
examinations — Specifications
Voting begins on:
for pre-examination processes
for urine and other body fluids —
Voting terminates on:
Isolated cell free DNA
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 18704:2024(en)
ii
ISO/DIS 18704:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3  Terms and definitions . 1
4 General requirements . 6
5 Outside the laboratory . 7
5.1 Specimen collection .7
5.1.1 Information about the patient or specimen donor .7
5.1.2 Selection of the body fluid collection device by the laboratory .7
5.1.3 Urine and other body fluid specimen collection from the patient/donor and
stabilization procedures .8
5.1.4 Information about the specimen storage requirements at the body fluid
collection facility .9
5.2 Transport requirements .11
5.2.1 General .11
5.2.2 Transport using urine and other body fluid collection devices with cfDNA
stabilizers .11
5.2.3 Transport using urine and other body fluid collection devices without cfDNA
stabilizers . 12
6 Inside the laboratory .12
6.1 Specimen/sample reception . 12
6.2 Specimen/sample storage after transport and reception . 12
6.3 Urine and other body fluid specimen/sample processing prior to cfDNA isolation . 13
6.4 Storage requirements for urine and other body fluid samples after processing . 13
6.5 Isolation of urine and other body fluid cfDNA . 13
6.5.1 General . 13
6.5.2 Using a commercial cfDNA isolation kit approved for diagnostic use .14
6.5.3 Using a laboratory developed cfDNA isolation procedure .14
6.6 Quantity and quality assessment of isolated cfDNA . 15
6.6.1 General . 15
6.6.2 Quantity assessment of cfDNA . 15
6.6.3 Quality assessment of cfDNA . 15
6.7 Storage of isolated urine and other body fluid cfDNA.16
6.7.1 General .16
6.7.2 Storage of isolated urine and other body fluid cfDNA, isolated with a
commercially available kit . .16
6.7.3 Storage of isolated urine and other body fluid cfDNA, isolated with the
laboratory's own procedure .17
Annex A (informative) Effects of pre-examination storage of unstabilized urine on cfDNA .18
Annex B (informative) Effects of pre-examination storage of unstabilized and stabilized urine
on the amount of a specific cfDNA target sequence.22
Bibliography .24

iii
ISO/DIS 18704:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212, Medical laboratories and in vitro diagnostic
systems.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DIS 18704:2024(en)
Introduction
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress has been
achieved and is still expected by new technologies used to examine profiles of nucleic acids, proteins, and
metabolites in human tissues and body fluids (e.g. genomic, epigenomic, transcriptomic, proteomic and
metabolomic profiling). However, the profiles of these molecules can change drastically during specimen
collection, transport, storage and processing. This can make the outcome from diagnostics or research
unreliable or even result in failure because the subsequent examination will not measure the genuine cfDNA
profile as it was in the patient, but a profile altered by the pre-examination process. Therefore, specifying,
developing, verifying and validating preanalytical workflows has become an essential part of examination
[1]
development .
Most
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