SIST-TS CEN/TS 17626:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA

This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations 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.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
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 menschliche Proben - Isolierte Mikrobiom-DNA

Dieses Dokument legt Anforderungen fest und gibt Empfehlungen für die präanalytische Untersuchungsphase von menschlichem Untersuchungsmaterial aus u. a. Stuhl, Speichel, Haut und dem Urogenitalbereich, das für die DNA Untersuchung des Mikrobioms vorgesehen ist. Die präanalytische Phase vor der Untersuchung umfasst unter anderem Entnahme, Handhabung, Transport, Lagerung und Verarbeitung des Untersuchungsmaterials, die Isolierung der DNA und die Dokumentation.
Dieses Dokument ist anwendbar auf molekulare in vitro-diagnostische Untersuchungen, die in medizinischen Laboratorien durchgeführt werden. Es ist außerdem für die Verwendung durch Kunden des Laboratoriums, Entwickler und Hersteller von In vitro-Diagnostika sowie Biobanken, Einrichtungen und kommerzielle Organisationen, die biomedizinische Forschungen durchführen, und Aufsichtsbehörden vorgesehen.
Für die präanalytischen Prozesse zur Untersuchung von Infektionskrankheiten (z. B. gezielte Erreger-identifizierung) und zur DNA Untersuchung des Mikrobioms aus Gewebe (z. B. Biopsien) sind andere zweckbestimmte Maßnahmen zu treffen. Diese liegen außerhalb des Anwendungsbereichs dieses Dokuments.
Für die präanalytischen Prozesse von Speichelproben zur genomischen Untersuchung menschlicher DNA sind andere zweckbestimmte Maßnahmen zu treffen. Diese werden nicht in diesem Dokument, sondern in CEN/TS 17305, Molekularanalytische in vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Speichel - Isolierte menschliche DNA, behandelt.
ANMERKUNG Für bestimmte Bereiche, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.

Analyses moléculaires de diagnostic in vitro - Spécifications relatives aux processus préanalytiques pour les échantillons humains - ADN du microbiote isolé

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za vzorce človeškega tkiva - Izolirana mikrobiom DNA

General Information

• Status: Published
• Public Enquiry End Date: 09-Feb-2021
• Publication Date: 24-May-2021
• ICS: 11.100.01 - Laboratory medicine in general
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-May-2021
• Due Date: 18-Jul-2021
• Completion Date: 25-May-2021
• Ref Project: CEN/TS 17626:2021 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vzorce človeškega tkiva - Izolirana mikrobiom DNA
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for human specimen - Isolated microbiome DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für menschliche Proben - Isolierte Mikrobiom-DNA
Analyses moléculaires de diagnostic in vitro - Spécifications relatives aux processus
préanalytiques pour les échantillons humains - ADN du microbiote isolé
Ta slovenski standard je istoveten z: CEN/TS 17626:2021
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 17626
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2021
TECHNISCHE SPEZIFIKATION
ICS 11.100.01
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for human specimen -
Isolated microbiome DNA
Analyses moléculaires de diagnostic in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour les échantillons humains - ADN du microbiote menschliche Proben - Isolierte Mikrobiom-DNA
isolé
This Technical Specification (CEN/TS) was approved by CEN on 19 March 2021 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17626:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General considerations . 11
5 Outside the laboratory . 12
5.1 Specimen collection . 12
5.1.1 General . 12
5.1.2 Information about the patient/specimen donor . 13
5.1.3 Specific information about the patient/specimen donor . 13
5.1.4 Selection of specimen collection method and device(s) . 15
5.1.5 Specimen collection from the patient/specimen donor and specimen stabilization. 16
5.2 Specimen storage and transport . 18
5.2.1 General . 18
5.2.2 Using collection devices with stabilizers . 19
5.2.3 Using collection devices without stabilizers . 19
6 Inside the laboratory . 20
6.1 Specimen reception . 20
6.2 Processing of specimens . 20
6.3 Specimen storage before microbiome DNA isolation . 21
6.4 Isolation of microbiome DNA . 21
6.4.1 General . 21
6.4.2 Using a commercial kit . 22
6.4.3 Using a laboratory developed procedure . 23
6.5 Quantity and quality assessment of isolated microbiome DNA . 23
6.5.1 General . 23
6.5.2 Quantity assessment . 24
6.5.3 Quality assessment . 24
6.6 Storage of isolated microbiome DNA . 24
6.6.1 General . 24
6.6.2 Microbiome DNA isolated using a commercial kit . 25
6.6.3 Microbiome DNA isolated using a laboratory developed procedure . 25
Annex A (informative) Impact of various pre-analytical variables on microbiome DNA
quantity, quality and profile . 26
A.1 Introduction . 26
A.2 Result – Impact of specimen stabilization method on isolated microbiome DNA
quantity . 26
A.2.1 General . 26
A.2.2 Method . 26
A.2.3 Result/conclusion . 27
A.3 Result – Impact of specimen to stabilizer mass/volume ratio on isolated microbiome
DNA quantity and quality. 28
A.3.1 General . 28
A.3.2 Method . 28
A.3.3 Result/conclusion . 28
A.4 Result – Impact of different microbiome DNA isolation methods on microbiome DNA
profile. 29
A.4.1 General . 29
A.4.2 Method . 29
A.4.3 Result/conclusion . 30
A.5 Results – Impact of stabilization status and storage of collected specimens/samples
on microbiome DNA profile . 31
A.5.1 General . 31
A.5.2 Method . 31
A.5.3 Result/conclusion . 32
Annex B (informative) Importance of using an in-process quality control material . 33
B.1 Introduction . 33
B.2 Results . 33
B.2.1 General . 33
B.2.2 Method . 33
B.2.3 Result . 35
B.3 Conclusions . 35
Bibliography . 36

European foreword
This document (CEN/TS 17626:2021) 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.
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, Turkey and the
United Kingdom.
Introduction
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is
expected using new technologies analysing the microbiome (e.g. bacteria, fungi, viruses, yeasts,
archaea) in human specimens.
The human microbiome has come into focus in many medical disciplines such as gastroenterology,
dermatology, or gynaecology as a potential biomarker for diagnosis and management of diseases, and
even as a therapeutic agent. Technologies analysing microbiome DNA such as shotgun metagenome or
amplicon-based sequencing (e.g. 16S or 18S rRNA gene sequencing) have accelerated this process and
are being increasingly perform
...