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 which should be taken into account when 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 fest, die bei der Durchführung einer Einzellabor-Validierungsstudie für Verfahren der qualitativen (binären) Realtime-Polymeraseketten¬reaktion (PCR) zum Nachweis spezifischer DNA-Sequenzen in Lebensmitteln beachtet werden sollten.
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 qu’il convient de prendre en compte lors de 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

Ta dokument opisuje značilnosti delovanja in minimalna merila učinkovitosti, ki jih je treba upoštevati pri izvajanju 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.
Protokol je bil razvit za kvalitativne metode PCR v realnem času za odkrivanje zaporedij DNA, pridobljenih iz gensko spremenjenih živil. Velja tudi za validacijo kvalitativnih metod PCR, uporabljenih za analizo drugih živilskih materialov, npr. za odkrivanje in identifikacijo vrst.
Dokument ne zajema vrednotenja uporabnosti in izvedljivosti glede na specifično področje uporabe metode PCR.

General Information

Status
Withdrawn
Publication Date
09-Apr-2019
Withdrawal Date
22-Jun-2021
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
23-Jun-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17329-1:2019
01-julij-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 17329-1:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST-TS CEN/TS 17329-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TS CEN/TS 17329-1:2019

---------------------- Page: 2 ----------------------

SIST-TS CEN/TS 17329-1:2019


CEN/TS 17329-1
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 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 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 17329-1:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST-TS CEN/TS 17329-1:2019
CEN/TS 17329-1:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Principle . 6
5 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 . 13
B.2 Dilution series of the
...

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17329-1:2019
01-januar-2019
äLYLOD6SORãQHVPHUQLFH]DYDOLGDFLMRNYDOLWDWLYQLKPHWRG3&5YUHDOQHPþDVX
GHO9DOLGDFLMDYSRVDPH]QHPODERUDWRULMX
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
Ta slovenski standard je istoveten z: FprCEN/TS 17329-1
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
kSIST-TS FprCEN/TS 17329-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TS FprCEN/TS 17329-1:2019

---------------------- Page: 2 ----------------------
kSIST-TS FprCEN/TS 17329-1:2019


FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17329-1
SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION

November 2018
ICS 67.050
English Version

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


This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 275.

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.

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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17329-1:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
kSIST-TS FprCEN/TS 17329-1:2019
FprCEN/TS 17329-1:2018 (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 . 13
B.2 Dilution series of the target DNA . 13
B.3 Preparation of PCR replicates . 13
B.4 Preparation of concentration levels for determination of the limit of detection
(LOD ) .
...

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