FprCEN/TS 17981-1
(Main)In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research.
This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 1: Untersuchung von menschlicher DNA
Dieses Dokument legt Anforderungen und Empfehlungen für Arbeitsabläufe bei der Sequenzierung der nächsten Generation (NGS) für die In vitro-Diagnostik und biomedizinische Forschung fest. Dieses Dokument behandelt die präanalytischen Prozesse, die Isolierung humaner DNA (somatischer und Keimbahn-DNA), die Vorbereitung einer Sequenzierungsbibliothek, die Sequenzierung, die Sequenzanalyse und die Berichterstellung über die Untersuchung der Sequenzen für diagnostische Zwecke, ausgehend von isolierter DNA, z. B. aus formalinfixierten und paraffineingebetteten Geweben, aus frisch eingefrorenen Gewebeproben, Feinnadelaspiraten (FNAs), Vollblut, zirkulierenden Tumorzellen (CTCs), Exosomen und anderen extrazellulären Vesikeln, zirkulierender zellfreier DNA aus Plasma sowie der aus Speichel stammenden DNA.
ANMERKUNG 1 Typische Anwendungen umfassen, ohne darauf beschränkt zu sein, NGS für die Onkologie, Pharmakogenomik und klinische Genetik; Vorgehensweisen sind beispielsweise z. B. Panel-Untersuchungen (z. B. krankheitsbezogene Panels, Exom-Panels, Zielgen-Panels und In silico-Panels), Exom- und Ganzgenom-Sequenzierung sowie bestimmte epigenetische und bestimmte Einzelzell-Analysen.
Dieses Dokument gilt für molekulare in vitro-diagnostische Untersuchungen, wozu auch im Labor entwickelte Prüfungen zählen, die von medizinischen Laboratorien, Laboratorien der molekularen Pathologie und molekulargenetischen Laboratorien durchgeführt werden. Dieses Dokument ist darüber hinaus auf Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika sowie auf Biobanken, Institutionen und Organisationen, die biomedizinische Forschungen durchführen, anwendbar.
Dieses Dokument gilt nicht für die In situ-Sequenzierung, DNA vermittelte Proteinsequenzierung, forensische Sequenzierung, Sequenzierung von Pathogenen oder Mikroorganismen sowie die Mikrobiomanalyse.
ANMERKUNG 2 Internationale, nationale oder regionale Regelungen bzw. Anforderungen, oder mehrere von ihnen, können ebenfalls für bestimmte Themen in diesem Dokument gelten.
Diagnostic in vitro Séquençage de nouvelle génération (NGS) pour des examens de l'ADN/ARN humain
No Scope Available
In vitro diagnostični delovni postopki Sekvenciranje naslednje generacije (NGS) - 1. del: Preiskava človeškega DNK
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17981-1:2023
01-september-2023
In vitro diagnostični delovni postopki Sekvenciranje naslednje generacije (NGS) -
1. del: Preiskava človeškega DNK
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA
examination
Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 1:
Untersuchung von menschlicher DNA
Diagnostic in vitro Séquençage de nouvelle génération (NGS) pour des examens de
l'ADN/ARN humain
Ta slovenski standard je istoveten z: FprCEN/TS 17981-1
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
kSIST-TS FprCEN/TS 17981-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TS FprCEN/TS 17981-1:2023
FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17981-1
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
June 2023
ICS 11.100.10
English Version
In vitro diagnostic Next Generation Sequencing (NGS)
workflows - Part 1: Human DNA examination
Diagnostic in vitro Séquençage de nouvelle génération Next Generation Sequencing (NGS)-Arbeitsabläufe für
(NGS) pour des examens de l'ADN/ARN humain die In-vitro-Diagnostik - Teil 1: Untersuchung von
menschlicher DNA
This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 140.
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, Türkiye and
United Kingdom.
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.
Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17981-1:2023 E
worldwide for CEN national Members.
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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements . 19
4.1 General. 19
4.2 Examination design . 20
4.3 Examination development . 24
4.4 Examination performance verification and validation . 24
4.5 Technical examination performance characteristics . 30
5 Pre-examination processes for examination development . 30
5.1 General. 30
5.2 Human DNA isolation . 32
5.3 DNA sample quality and quantity evaluation . 33
6 Examination processes for examination development . 35
6.1 Sequencing library preparation for examination development . 35
6.2 Sequencing examination development . 40
6.3 Data analysis requirements for examination development . 41
6.4 Quality control (QC) requirements for examination development . 42
7 Requirements for the development of the examination reporting tool . 43
7.1 General. 43
7.2 Report attributes . 44
7.3 Report content . 44
8 Implementation of the in vitro diagnostic NGS workflow into routine practice . 45
9 Reporting and interpretation of results . 46
10 Quality assurance procedures . 47
10.1 General. 47
10.2 Performance monitoring, optimization of the examination and interlaboratory
comparison . 47
Annex A (normative) in vitro diagnostic NGS workflow for single-cell analyses . 48
A.1 General information and requirements on single-cell analyses . 48
A.2 Pre-examination processes for examination development . 49
A.3 Examination phase for examination development. 53
A.4 Implementation of the in vitro diagnostic NGS workflow into routine practice . 54
A.5 Reporting and interpretation of results . 54
A.6 Quality assurance procedures . 54
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Annex B (informative) NGS workflow scheme for the examination of DNA . 55
Bibliography . 56
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European foreword
This document (FprCEN/TS 17981-1:2023) has been prepared by Technical Committee CEN/TC 140 “In
vitro diagnostic medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the Vote on TS.
A list of all parts in this series can be found on the CEN website: www.cencenelec.eu.
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Introduction
Molecular in vitro diagnostics has enabled 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. Next Generation Sequencing (NGS) takes a prominent place in the series of molecular
techniques used for diagnostics. It facilitates sequence analysis of nucleic acids that can result in precise
information for diagnosis and progression of diseases.
The NGS technique, however, has a very complex workflow that contains many steps. The target nucleic
acids can originate from different sources, e.g. tissues, blood, and body fluids. The profiles of the isolated
DNA or methylated DNA can change during specimen collection, transport, storage and processing (e.g.
formalin fixation), 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. The available material can be small, the cells in a
tissue can be dispersed heterogeneously (e.g. ratio of tumour to normal), the target nucleic acids can be
circulating in blood or body fluids free of cells or in circulating cells (e.g. circulating tumour cells (CTC’s)).
For a successful and reliable sequence result, a suitable strategy needs to be chosen for every case
depending on the available material and disease conditions. Therefore, the NGS workflow can differ from
case to case, and the NGS workflow steps need to be carefully considered and chosen to get a sound and
reliable result to determine the best available treatment for the patient. In addition, sequence platforms
can differ in their technique (e.g. detection of a change in a current or fluorescence) and approach (e.g.
panels, short-read sequencing, long-read sequencing) for sequence assessment. The bioinformatics
analysis can differ in approach and ability to detect non-conformities and unreliable sequence results. To
enable such capabilities, NGS metadata needs to be collected during all workflow steps from the patient
until the reporting. In addition, controls and added controls need to be analysed properly. In this way,
non-conformities or detected unreliabilities can be reported to the patient and the treating physician. The
reporting of diagnostic NGS results can differ in clarity and depth, which can lead to different
interpretations.
Standardization of the entire NGS workflow from specimen collection to the reporting of the results to
the patient and the treating physician is needed for the development of reliable NGS examinations.
This document draws upon previous work to standardize the steps for NGS examinations from tissues,
blood and body fluids in what is referred to as the pre-examination phase (sample collection), the
examination phase (library preparation, sequencing), and the post-examination phase (analysis and
reporting).
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.
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1 Scope
This document specifies requirements and gives recommendations for next generation sequencing (NGS)
workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination
processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing,
sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated
DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates
(FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles,
circulating cell free DNA from plasma, and DNA from saliva.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical
genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels),
exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed
tests performed by medical laboratories, molecular pathology laboratories and molecular genetic
laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers
and manufacturers, biobanks, institutions, and organizations performing biomedical research.
This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic
sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them 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.
CEN/TS 17390-2:2020, Molecular in vitro diagnostic examinations - Specifications for pre-examination
processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
CEN/TS 17688-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
CEN/TS 17747, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
CEN/TS 17811, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for urine and other body fluids - Isolated cell free DNA
EN ISO 4307, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for
saliva - Isolated human DNA (ISO 4307)
EN ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes (ISO
13485)
EN ISO 15189:2022, Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
EN ISO/IEC 17020:2012, Conformity assessment - Requirements for the operation of various types of bodies
performing inspection (ISO/IEC 17020:2012)
EN ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories
(ISO/IEC 17025:2017)
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EN ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3)
EN ISO 20184-3:2021, Molecular in vitro diagnostic examinations - Specifications for pre-examination
processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
EN ISO 20186-2:2019, Molecular in vitro diagnostic examinations - Specifications for pre-examination
processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
EN ISO 20186-3:2019, Molecular in vitro diagnostic examinations - Specifications for pre-examination
processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
(ISO 20186-3:2019)
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 20397-1:2022, Biotechnology — Massively parallel sequencing — Part 1: Nucleic acid and library
preparation
ISO 20397-2, Biotechnology — Massively parallel sequencing — Part 2: Quality evaluation of sequencing
data
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 15189:2022 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://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 [1] [2] [3].
[SOURCE: EN ISO 20184-3:2021, 3.1, modified ─ Note 2 to entry was added.]
3.2
amplicon
specific DNA fragment produced by a DNA-amplification technology, such as the polymerase chain
reaction (PCR)
[SOURCE: ISO 13495:2013, 3.3.1]
3.3
analyte
component represented in the name of a measurable quantity
[SOURCE: EN ISO 17511:2021, 3.2]
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3.4
analytical accuracy
closeness of the agreement between the result of an examination and a true value
Note 1 to entry: For NGS-based examinations, accuracy represents the degree of concordance (or agreement) of
results between a sequence obtained from the examination and the same sequence determined by a valid
comparator method, or between a reference sample run on an NGS-based examination and the high confidence
sequence of the reference.
3.5
analytical sensitivity
sensitivity of a measurement procedure
quotient of the change in a measurement indication and the corresponding change in a value of a quantity
being measured
Note 1 to entry: The sensitivity of a measurement procedure can depend on the value of the quantity being
measured.
Note 2 to entry: The change considered in the value of the quantity being measured shall be large compared with
the resolution.
Note 3 to entry: The analytical sensitivity of a measuring system is the slope of the calibration curve.
Note 4 to entry: Analytical sensitivity is often confused with positive percentage agreement (PPA), because similar
calculations are used for both the analytical sensitivity and the PPA. However, the term PPA instead of analytical
sensitivity is only used, if a reference method is not available or is not used. The PPA represents merely an
estimation of the analytical sensitivity. PPA is applicable only to measurements of quantities that have the nature of
a count.
[SOURCE: ISO/IEC Guide 99:2007, 4.12, modified — Note 4 was deleted and a new Note 4 was added.]
3.6
analytical specificity
capability of a measuring system, using a specified measurement procedure, to provide measurement
results for one or more measurands which do not depend on each other nor on any other quantity in the
system undergoing measurement
Note 1 to entry: Lack of analytical specificity is called analytical interference (see ISO 18113-1:2009, A.3.2).
Note 2 to entry: Specificity of a measurement procedure is not to be confused with clinical specificity (see
ISO 18113-1:2009, A.3.16).
Note 3 to entry: VIM; JCGM 200:2012 uses the term selectivity for this concept instead of specificity.
Note 4 to entry: For qualitative and semiquantitative examination procedures, analytical specificity is determined
by the ability to obtain negative results in concordance with negative results obtained by the reference method.
Note 5 to entry: Analytical specificity is often confused with negative percentage agreement (NPA), because the
same calculations are used for both the analytical specificity and the NPA. However, the term NPA instead of
analytical specificity is only used, if a reference method is not available or is not used. The NPA represents merely
an estimation of the analytical specificity.
[SOURCE: ISO 18113-1:2009, A.3.4, modified — “should” was replaced by “is” and Note 5 was added.]
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3.7
bioinformatics pipeline
suite of different bioinformatics tools that process the NGS data
3.8
ccfDNA
circulating cell free DNA
extracellular human DNA present in blood and plasma
Note 1 to entry: ccfDNA includes DNA present in vesicles such as exosomes.
[SOURCE: EN ISO 20186-3:2019, 3.5]
3.9
cfDNA
cell free DNA
extracellular human DNA present in body liquids such as urine
Note 1 to entry: cfDNA can include DNA present in vesicles such as exosomes.
[SOURCE: CEN/TS 17811:2022, 3.8]
3.10
clinical accuracy
diagnostic accuracy
extent of agreement between the outcome of the new examination and the reference method
3.11
clinical performance
ability of an examination to yield results that are correlated with a particular clinical condition,
physiological or pathological state in accordance with the target population and intended use(r)
Note 1 to entry: Although sometimes referred to as diagnostic performance or clinical validity; clinical
performance is the harmonized term endorsed by the Global Harmonization Task Force (GHTF) and its successor,
the International Medical Devices Regulators Forum (IMDRF).
Note 2 to entry: Evaluation of clinical performance often relies on the outcome of other types of clinical
examinations to define “true positive or true negative” results.
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3.12
clinical sensitivity
diagnostic sensitivity
ability of an in vitro diagnostic examination procedure to identify the presence of a target marker
associated with a specific disease or condition
Note 1 to entry: percent positivity in samples where the target marker is known to be present.
Note 2 to entry: Diagnostic sensitivity is expressed as a percentage (number fraction multiplied by 100), calculated
as 100 × the number of true positive values (TP) divided by the sum of the number of true positive values (TP) plus
the number of false negative values (FP), or 100 × TP/(TP + FN). This calculation is based on a study design where
only one sample is taken from each subject.
Note 3 to entry: The target condition is defined by criteria independent of the examination procedure under
consideration.
Note 4 to entry: Clinical sensitivity is often confused with positive percentage agreement (PPA), because the same
calculations are used for both the clinical sensitivity and the PPA. However, the term PPA instead of clinical
sensitivity is only used, if a reference method is not available or is not used. The PPA represents merely an
estimation of the clinical sensitivity.
[SOURCE: ISO 18113-1:2009, A.3.15, modified — “” was deleted and Note 4 was
added.]
3.13
clinical specificity
diagnostic specificity
ability of an in vitro diagnostic examination procedure to recognise the absence of a target marker
associated with a specific disease or condition
Note 1 to entry: Also defined as percent negativity in samples where the target marker is known to be absent.
Note 2 to entry: Clinical specificity is expressed as a percentage (number fraction multiplied by 100), calculated as
100 × the number of true negative values (TN) divided by the sum of the number of true negative plus the number
of false positive values (FP), or 100 × TN/(TN + FP). This calculation is based on a study design where only one
sample is taken from each subject.
Note 3 to entry: The target condition is defined by criteria independent of the examination procedure under
consideration.
Note 4 to entry: Clinical specificity is often confused with negative percentage agreement (NPA), because the same
calculations are used for both the clinical specificity and the NPA. However, the term NPA instead of clinical
specificity is only used, if a reference method is not available or is not used. The NPA represents merely an
estimation of the clinical specificity.
[SOURCE: ISO 18113-1:2009, A.3.16, modified — “” was deleted and Note 4 was
added.]
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3.14
clinical utility
ability of a screening or diagnostic examination to prevent or ameliorate adverse health outcomes such
as mortality, morbidity, or disability through the adoption of efficacious treatments conditioned on
examination results
Note 1 to entry: Clinical utility can be part of scientific validity and clinical performance [4] [5].
[SOURCE: [4]]
3.15
clinical validity
predictive value of a test for a given clinical outcome
Note 1 to entry: Clinical validity is primarily determined by the sensitivity and specificity with which a test
identifies individuals with a defined clinical condition within a given population. The clinical validity of a genetic
test is the likelihood that, e.g. cancer will develop in someone with a positive test result.
3.16
closed system
non-modifiable system provided by the vendor including all necessary components for the examination
(i.e., hardware, software, procedures and reagents)
3.17
diagnosis
identification of a disease from its signs and 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
3.18
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]
3.19
DNA sequencing
determining the order of nucleotide bases (adenine, guanine, cytosine and thymine) in a molecule of DNA
Note 1 to entry: Sequence is generally described from the 5’ end.
[SOURCE: ISO 17822:2020, 3.19]
3.20
epigenetics
study of changes in expression or gene function that are mitotically and/or meiotically heritable and that
do not entail a change in DNA sequence
[SOURCE: [6]]
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3.21
EV
extracellular vesicle
particle naturally released from the cell that are delimited by a lipid bilayer and cannot replicate, i.e. does
not contain a functional nucleus
EXAMPLE Exosomes, endosomes, oncosomes, apoptotic bodies.
[SOURCE: [7]]
3.22
examination
analytical test
set of operations having the objective of determining the numerical value or characteristics of a property
[SOURCE: EN ISO 15189:2022, 3.8, modified — Notes to entry 1 to 3 have been removed. “analytical test”
has been added as a preferred term.]
3.23
examination manufacturer
analytical test manufacturer
entity that manufactures and/or produces a specific analytical test
[SOURCE: EN ISO 20166-4:2021, 3.16]
3.24
examination performance
analytical test performance
analytical performance
ability of an examination procedure to measure or detect a particular analyte
Note 1 to entry: Analytical performance is determined from analytical performance studies used to assess the
ability of an in vitro diagnostic examination procedure to measure or detect a particular analyte.
Note 2 to entry: Analytical performance includes such characteristics as analytical sensitivity, detection limit,
analytical specificity (interference and cross-reactivity), trueness, precision and linearity.
[SOURCE: EN ISO 20186-3:2019, 3.11]
3.25
formalin
saturated aqueous formaldehyde solution which at 100% contains 37% formaldehyde by mass
(corresponding to 40 % by volume)
[SOURCE: EN ISO 20166-1:2018, 3.11]
3.26
FNA
fine needle aspirate
specimen withdrawn by a non-operative procedure that uses a thin, hollow-bore needle
[SOURCE: CEN/TS 17688-1:2021, 3.18]
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3.27
in-house examination
laboratory developed examination
examination manufactured or modified and used by health institutions or medical laboratories intended
to be used only in their facility, to fulfil specific needs of target patient groups which cannot be met by an
equivalent IVD examination available on the market at the appropriate level of performance
Note 1 to entry: In-house examination is also often referred to as a laboratory developed test (LDT).
3.28
intended use
intended purpose
use of a product, process or service intended for medical purposes in accordance with the specifications,
instructions and information provided by the manufacturer
Note 1 to entry: The intended purpose indicates the object to be detected/measured, the examination’s function
(screening, monitoring, diagnosis, prognosis, companion diagnostic), if the examination is automated, specific
information to be provided as a component of the device (to determine physiological/pathological state, clinical
condition or predisposition, prediction to treatment response/reaction or monitoring of a therapy or non-
proprietary name of the medicinal prod
...
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