CEN ISO/TS 5798:2022
(Main)In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
In-vitro-Diagnostika-Systeme - Anforderungen und Empfehlungen für Qualitätsverfahren für den Nachweis des Coronavirus 2 des Schweren Akuten Respiratorischen Syndroms (SARS-CoV-2) mittels Nukleinsäureamplifikation (ISO/TS 5798:2022)
Dieses Dokument enthält Anforderungen und Empfehlungen für Design, Entwicklung, Verifizierung, Validierung und Umsetzung von analytischen Tests zum Nachweis des Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) unter Anwendung der Nukleinsäure-Amplifikation. Es befasst sich mit den präanalytischen, analytischen und postanalytischen Verfahrensschritten zur Untersuchung menschlicher Primärproben.
Dieses Dokument ist für die Anwendung in medizinischen Laboratorien vorgesehen. Es ist darüber hinaus für die Anwendung durch Entwickler und Hersteller von In vitro-Diagnostika sowie durch Einrichtungen und Organisationen bestimmt, die die SARS CoV 2-Forschung und Diagnostik unterstützen.
Dieses Dokument ist nicht anwendbar auf Umweltproben.
Systèmes d’essai pour diagnostic in vitro - Exigences et recommandations pour la détection du coronavirus 2 associé au syndrome respiratoire aigu sévère (SARS-CoV-2) par des méthodes d’amplification des acides nucléiques (ISO/TS 5798:2022)
Le présent document fournit des exigences et des recommandations pour la conception, le développement, la vérification, la validation et la mise en œuvre d’analyses afin de détecter le coronavirus 2 du syndrome respiratoire aigu sévère (SARS‑CoV‑2) au moyen de l’amplification de l’acide nucléique. Il aborde les étapes du processus préanalytique, de l’analyse et du processus postanalytique pour des spécimens humains.
Le présent document s’applique aux laboratoires de biologie médicale. Il est également destiné aux concepteurs et fabricants de diagnostics in vitro, ainsi qu’aux institutions et aux organisations soutenant la recherche et le diagnostic du SARS‑CoV‑2.
Le présent document ne s’applique pas aux échantillons environnementaux.
Diagnostični preskusni sistemi in vitro - Zahteve in priporočila za odkrivanje koronavirusa (SARS-CoV-2) z metodami amplifikacije nukleinskih kislin (ISO/TS 5798:2022)
Ta dokument določa zahteve in priporočila za načrtovanje, razvoj, preverjanje, potrjevanje ter izvedbo analitičnih preskusov za odkrivanje koronavirusa 2 – hudega akutnega respiratornega sindroma (SARS-CoV-2) z amplifikacijo nukleinskih kislin. Obravnava korake predpreiskovalnega, preiskovalnega in popreiskovalnega postopka za človeške vzorce.
Ta dokument se uporablja za medicinske laboratorije. Uporabljali naj bi ga tudi razvijalci in proizvajalci diagnostike in vitro ter institucije in organizacije, ki spodbujajo raziskave in diagnostiko v zvezi z virusom SARS-CoV-2.
Ta dokument se ne uporablja za okoljske vzorce.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2023
Diagnostični preskusni sistemi in vitro - Zahteve in priporočila za odkrivanje
koronavirusa (SARS-CoV-2) z metodami amplifikacije nukleinskih kislin (ISO/TS
5798:2022)
In vitro diagnostic test systems - Requirements and recommendations for detection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid
amplification methods (ISO/TS 5798:2022)
In-vitro-Diagnostika-Systeme - Anforderungen und Empfehlungen für Qualitätsverfahren
für den Nachweis des Coronavirus 2 des Schweren Akuten Respiratorischen Syndroms
(SARS-CoV-2) mittels Nukleinsäureamplifikation (ISO/TS 5798:2022)
Systèmes d’essai pour diagnostic in vitro - Exigences et recommandations pour la
détection du coronavirus 2 associé au syndrome respiratoire aigu sévère (SARS-CoV-2)
par des méthodes d’amplification des acides nucléiques (ISO/TS 5798:2022)
Ta slovenski standard je istoveten z: CEN ISO/TS 5798:2022
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 ISO/TS 5798
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
November 2022
TECHNISCHE SPEZIFIKATION
ICS 11.100.01
English Version
In vitro diagnostic test systems - Requirements and
recommendations for detection of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid
amplification methods (ISO/TS 5798:2022)
Systèmes d'essai pour diagnostic in vitro - Exigences et In-vitro-Diagnostika-Systeme - Anforderungen und
recommandations pour la détection du coronavirus 2 Empfehlungen für Qualitätsverfahren für den
associé au syndrome respiratoire aigu sévère (SARS- Nachweis des Coronavirus 2 des Schweren Akuten
CoV-2) par des méthodes d'amplification des acides Respiratorischen Syndroms (SARS-CoV-2) mittels
nucléiques (ISO/TS 5798:2022) Nukleinsäureamplifikation (ISO/TS 5798:2022)
This Technical Specification (CEN/TS) was approved by CEN on 21 November 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, Türkiye 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 ISO/TS 5798:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO/TS 5798:2022 has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems” of the International Organization for
Standardization (ISO) and has been taken over as CEN ISO/TS 5798:2022 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 organizations 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 5798:2022 has been approved by CEN as CEN ISO/TS 5798:2022 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 5798
First edition
2022-04
In vitro diagnostic test systems —
Requirements and recommendations
for detection of severe acute
respiratory syndrome coronavirus 2
(SARS-CoV-2) by nucleic acid
amplification methods
Systèmes d’essai pour diagnostic in vitro — Exigences et
recommandations pour la détection du coronavirus 2 associé au
syndrome respiratoire aigu sévère (SARS-CoV-2) par des méthodes
d’amplification des acides nucléiques
Reference number
ISO/TS 5798:2022(E)
ISO/TS 5798:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO/TS 5798:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Overview . 7
4.1 SARS-CoV-2 . 7
4.1.1 General . 7
4.1.2 Pre-examination . 9
4.1.3 Examination — Overview . 9
4.1.4 Post-examination . 11
4.2 Nucleic acid amplification methods . 11
4.2.1 Reverse transcription qPCR (RT-qPCR) . 11
4.2.2 Reverse transcription digital PCR (RT-dPCR) .12
4.2.3 Isothermal amplification methods .12
5 Laboratory requirements .12
5.1 General .12
5.2 Biosafety requirements . 13
5.2.1 Laboratory area . 13
5.2.2 Risk control . 13
5.2.3 Personal protective equipment (PPE) . 13
5.3 General laboratory set-up .13
5.4 Instrumentation . 14
5.5 Laboratory personnel . 14
6 Design and development .14
6.1 Customer, patient and stakeholder needs . 14
6.2 Intended use of analytical test . 14
6.3 Institutional guideline strategy . 15
6.3.1 Laboratory developed tests (LDTs) versus in vitro diagnostic medical
devices (IVD medical devices) . 15
6.3.2 Emergency use authorization . 15
6.4 Clinical strategy . 15
6.5 Design and development planning . 16
6.5.1 Pre-examination of respiratory specimens for SARS-CoV-2 testing. 16
6.5.2 Examination design specifications (analytical test specifications) .22
6.5.3 Design risk management . 27
6.6 Optimization of reagents and methods .28
6.6.1 Selection of SARS-CoV-2 target sequences .28
6.6.2 Potential impact of variants of concern (VOCs) on the quality of NAAT
diagnostic methods for detecting SARS-CoV-2.28
6.6.3 Selection of amplification methods .28
6.6.4 Design and selection of primers .28
6.6.5 Optimization of the reaction system .29
6.6.6 Determination of cut-off values .29
6.6.7 Verification and validation of test design .29
7 Verification for pati
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