CEN/TS 17329-1:2021

Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Single-laboratory validation

This document describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

Lebensmittel - Allgemeine Anleitung für die Validierung qualitativer Realtime-PCR-Verfahren - Teil 1: Einzellaborvalidierung

Dieses Dokument legt die Leistungsmerkmale und Mindestleistungskriterien für die Durchführung einer Einzellabor-Validierungsstudie für Verfahren der qualitativen (binären) Realtime-Polymerasekettenreaktion (PCR) zum Nachweis spezifischer DNA-Sequenzen in Lebensmitteln fest.
Diese Vorschrift wurde entwickelt für qualitative Realtime-PCR-Verfahren zum Nachweis von DNA-Sequenzen, die von gentechnisch modifizierten Lebensmitteln stammen. Darüber hinaus ist es anwendbar für die Einzellaborvalidierung von qualitativen PCR-Verfahren, die zur Analyse sonstiger Lebensmittel eingesetzt werden, z. B. für den Nachweis und die Identifizierung von Spezies.
Das Dokument befasst sich nicht mit der Evaluierung der Anwendbarkeit und der Durchführbarkeit im Zusammenhang mit dem spezifischen Anwendungsbereich des PCR-Verfahrens.

Denrées alimentaires - Lignes directrices générales pour la validation des méthodes de PCR qualitative en temps réel - Partie 1 : Validation intralaboratoire

Le présent document décrit les caractéristiques de performance et les critères de performance minimaux pour la réalisation d’une étude de validation intralaboratoire relative aux méthodes de réaction en chaîne par polymérase (PCR) qualitative (binaire) en temps réel appliquées pour la détection de séquences d’ADN spécifiques présentes dans les aliments.
Le protocole a été mis au point pour les méthodes de PCR qualitative en temps réel appliquées pour la détection de séquences d’ADN extraites de produits alimentaires génétiquement modifiés. Il est également applicable à la validation intralaboratoire des méthodes de PCR qualitative utilisées pour l’analyse d’autres produits alimentaires, par exemple pour la détection et l’identification des espèces.
Le document ne couvre pas l’évaluation de l’applicabilité et de la faisabilité en ce qui concerne le domaine d’application spécifique de la méthode de PCR.

Živila - Splošne smernice za validacijo kvalitativnih metod PCR v realnem času - 1. del: Validacija v posameznem laboratoriju

General Information

• Status: Published
• Publication Date: 22-Jun-2021
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: CEN/TC 275 - Food analysis - Horizontal methods
• Drafting Committee: CEN/TC 275/WG 11 - Genetically modified foodstuffs
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Jun-2021
• Due Date: 12-Aug-2021
• Completion Date: 23-Jun-2021
• Directive: 2017/625 - Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
• Directive: 882/2004 - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
• Ref Project: SIST-TS CEN/TS 17329-1:2021 - Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Single-laboratory validation

Relations

• Replaces: CEN/TS 17329-1:2019 - Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Single-laboratory validation
• Effective Date: 30-Jun-2021
• Revised: prEN ISO 11781 - Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)
• Effective Date: 20-Apr-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17329-1:2021
01-september-2021
Nadomešča:
SIST-TS CEN/TS 17329-1:2019
Živila - Splošne smernice za validacijo kvalitativnih metod PCR v realnem času - 1.
del: Validacija v posameznem laboratoriju
Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods -
Part 1: Single-laboratory validation
Lebensmittel - Allgemeine Anleitung für die Validierung qualitativer Realtime-PCR-
Verfahren - Teil 1: Einzellaborvalidierung
Denrées alimentaires - Lignes directrices générales pour la validation des méthodes de
PCR qualitative en temps réel - Partie 1 : Validation intralaboratoire
Ta slovenski standard je istoveten z: CEN/TS 17329-1:2021
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST-TS CEN/TS 17329-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 17329-1:2021

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SIST-TS CEN/TS 17329-1:2021


CEN/TS 17329-1
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

June 2021
TECHNISCHE SPEZIFIKATION
ICS 67.050 Supersedes CEN/TS 17329-1:2019
English Version

Foodstuffs - General guidelines for the validation of
qualitative real-time PCR methods - Part 1: Single-
laboratory validation
Denrées alimentaires - Lignes directrices générales Lebensmittel - Allgemeine Anleitung für die
pour la validation des méthodes de PCR qualitative en Validierung qualitativer Realtime-PCR-Verfahren - Teil
temps réel - Partie 1 : Validation intralaboratoire 1: Einzellaborvalidierung
This Technical Specification (CEN/TS) was approved by CEN on 16 May 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.





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© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17329-1:2021 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 17329-1:2021
CEN/TS 17329-1:2021 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Principle . 6
5 Single-laboratory validation of the performance characteristics . 6
6 Validation report . 10
Annex A (informative) Estimation of the number of copies of the target sequence . 11
Annex B (informative) Determination of limit of detection, precision and PCR efficiency . 13
B.1 General .
...