CEN/TS 17305:2019

SLOVENSKI STANDARD
01-julij-2019
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za slino - Izolirana človeška DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for saliva - Isolated human DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Saliva - Isolierte menschliche DNS
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour la salive - ADN humain isolé
Ta slovenski standard je istoveten z: CEN/TS 17305:2019
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 17305
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
April 2019
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for saliva - Isolated human
DNA
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour la salive - ADN humain extrait Speichel - Isolierte menschliche DNA
This Technical Specification (CEN/TS) was approved by CEN on 21 January 2019 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17305:2019 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 . 10
5.1 Specimen collection . 10
5.1.1 Information about the specimen donor/patient . 10
5.1.2 Selection of the saliva collection device by the laboratory . 10
5.1.3 Saliva specimen collection from the donor/patient and stabilization procedures . 10
5.1.4 Information on the specimen and storage requirements at saliva collection
facility/site . 11
5.2 Transport requirements. 12
5.2.1 General . 12
5.2.2 Using saliva collection devices with DNA stabilizers . 12
5.2.3 Using saliva collection devices without DNA stabilizers . 12
6 Inside the laboratory . 12
6.1 Specimen reception . 12
6.2 Storage requirements . 13
6.3 Isolation of the saliva DNA . 13
6.3.1 General . 13
6.3.2 Using commercial kit . 13
6.3.3 Using the laboratories own protocol . 14
6.4 Quantity and quality assessment of isolated DNA . 14
6.5 Storage of isolated saliva DNA . 14
6.5.1 General . 14
6.5.2 Saliva DNA isolated with commercially available kits . 15
6.5.3 Saliva DNA isolated with the laboratory's own protocols . 15
Bibliography . 16

European foreword
This document (CEN/TS 17305:2019) 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, 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 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.
Genetic examination of DNA is commonly used in clinical practice. This includes e.g. predisposition
testing, pharmacogenomics, analysis of genetic disorders with the perspective use in precision
medicine. This is a fast growing field in molecular diagnostics.
Saliva is increasingly used as a non-invasive alternative specimen to blood for the examination of
human DNA. Saliva naturally contains microorganisms and also extraneous substances (e.g., food
debris), which make the composition of saliva more complex and unique among patients/donors.
Dedicated measures are therefore needed for informing and preparing patients/donors for the
collection and to check compliance with the instructions, in order to reduce the specimen variability. In
contrast to invasive specimen collection, saliva collection does not require trained and educated
professionals or dedicated facilities. By good instruction and verified collection device safety claims,
saliva specimens can be self-collected at home; however, home collection also contributes to high
variability in specimen quality. Similarly, medical laboratories/ in vitro manufacturers need to be aware
of specimen variability when performing design verification and validation.
DNA in saliva can fragment or degrade after collection. In addition, bacteria present in the saliva
specimen can continue to grow, thus diluting the human DNA. DNases secreted by these bacteria can
also accelerate the DNA degradation. This can impact the sensitivity and reliability of DNA examination.
Standardization of the entire process from specimen collection to the DNA examination is needed to
minimize DNA degradation and fragmentation after saliva collection. This document describes special
measures which need to be taken to obtain good quality saliva specimen/samples and isolated DNA
therefrom for human DNA 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 requirements on the handling, storage, processing and documentation of saliva
specimens intended for human 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. It is also intended to be used by laboratory
customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial
organisations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth
washes are not described in this technical specification. Neither are measures for preserving and
handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in
saliva described.
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)
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
ambient temperature
unregulated temperature of the surrounding air
3.2
analyte
component represented in the name of a measurable quantity
[SOURCE: ISO 17511:2003, 3.2 modified — The examples were not taken over.]
3.3
examination performance
analytical test performance
analytical 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.
[SOURCE: ISO 20184-1:2018, 3.4]
3.4
DNA stabilizers
compounds, solutions or mixtures that are designed to minimize degradation and fragmentation of DNA
3.5
closed system
non-modifiable system provided by the vendor including all necessary components for the analysis (i.e.,
hardware, software, procedures and reagents)
3.6
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]
3.7
DNA proficiency testing program
proficiency testing for DNA based examinations
Note 1 to entry: Commonly, a program periodically sends multiple specimens to members of a group of
laboratories for analysis and/or identification; the p
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