SIST-TS CEN/TS 17329-2:2019

Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 2: Collaborative study

This document provides information on how the performance characteristics of qualitative (binary) real-time polymerase chain reaction (PCR) methods for detection of specific DNA sequences present in foods should be evaluated and validated by conducting a collaborative study.
The guidelines are applicable for validation of qualitative PCR methods used for detection of DNA sequences derived from genetically modified foodstuffs. They can be applicable also for PCR methods used for detection of other target sequences in foodstuffs, e.g. for species detection and identification.

Lebensmittel - Allgemeine Anleitung für die Validierung qualitativer Realtime-PCR-Verfahren - Teil 2: Ringversuch

Dieses Dokument legt fest, wie die Leistungsmerkmale von Verfahren der qualitativen (binären) Realtime-Polymerasekettenreaktion (PCR) zum Nachweis von bestimmten, in Lebensmitteln vorliegenden DNA-Sequenzen in einem Ringversuch bewertet und validiert werden sollten.
Der Leitfaden wurde entwickelt für qualitative PCR-Verfahren zum Nachweis von DNA-Sequenzen, die von gentechnisch modifizierten Lebensmitteln stammen. Darüber hinaus lässt er sich anwenden bei PCR-Verfahren zum Nachweis von anderen Arten von Zielsequenzen in Lebensmitteln, z. B. für den Nachweis und die Identifizierung von Spezies.

Denrées alimentaires - Lignes directrices générales pour la validation des méthodes de PCR qualitative en temps réel - Partie 2 : Étude interlaboratoires

Le présent document fournit des informations sur la façon dont il convient d’évaluer et de valider, en effectuant une étude interlaboratoires, les caractéristiques de performance des méthodes de réaction en chaîne par polymérase (PCR) qualitative (binaire) en temps réel applicables à la détection de séquences d’ADN spécifiques présentes dans les aliments.
Les lignes directrices sont applicables à la validation des méthodes de PCR qualitative utilisées pour la détection de séquences d’ADN extraites de produits alimentaires génétiquement modifiés. Elles peuvent également être applicables aux méthodes de PCR utilisées pour la détection d’autres séquences cibles dans les produits alimentaires, par exemple pour la détection et l’identification des espèces.

Živila - Splošne smernice za validacijo kvalitativnih metod PCR v realnem času - 2. del: Medlaboratorijska študija

Ta dokument vsebuje informacije o tem, kako naj bi z izvedbo laboratorijske validacijske študije za kvalitativne (binarne) metode polimerazne verižne reakcije (PCR) v realnem času, ki se uporabljajo za odkrivanje določenih zaporedij DNA, prisotnih v živilih, ovrednotili in potrdili lastnosti delovanja.
Smernice se uporabljajo za validacijo kvalitativnih metod PCR za odkrivanje zaporedij DNA, pridobljenih iz gensko spremenjenih živil. Mogoče jih je uporabiti tudi za metode PCR, ki se uporabljajo za odkrivanje drugih ciljnih zaporedij v živilih, npr. za odkrivanje in identifikacijo vrst.

General Information

• Status: Published
• Public Enquiry End Date: 19-Jan-2019
• Publication Date: 26-May-2019
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 18-Apr-2019
• Due Date: 23-Jun-2019
• Completion Date: 27-May-2019
• 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: CEN/TS 17329-2:2019 - Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 2: Collaborative study

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17329-2:2019
01-julij-2019
Živila - Splošne smernice za validacijo kvalitativnih metod PCR v realnem času - 2.
del: Medlaboratorijska študija
Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods -
Part 2: Collaborative study
Lebensmittel - Allgemeine Anleitung für die Validierung qualitativer Realtime-PCR-
Verfahren - Teil 2: Ringversuch
Denrées alimentaires - Lignes directrices générales pour la validation des méthodes de
PCR qualitative en temps réel - Partie 2 : Étude interlaboratoires
Ta slovenski standard je istoveten z: CEN/TS 17329-2:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST-TS CEN/TS 17329-2:2019 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 17329-2:2019

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SIST-TS CEN/TS 17329-2:2019


CEN/TS 17329-2
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

April 2019
TECHNISCHE SPEZIFIKATION
ICS 67.050
English Version

Foodstuffs - General guidelines for the validation of
qualitative real-time PCR methods - Part 2: Collaborative
study
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 2 : Étude interlaboratoires 2: Ringversuch
This Technical Specification (CEN/TS) was approved by CEN on 25 February 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 17329-2:2019 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 17329-2:2019
CEN/TS 17329-2:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Principle . 6
5 Validation of the performance characteristics by means of a collaborative study . 6
6 Calculation of precision data for test samples . 11
7 Study report . 11
Annex A (informative) Instructions for the conduct of the collaborative study . 12
Annex B (informative) Statistical model . 20
Bibliography .
...