Abstract

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.

Begin

2022-04-20

WI

00275377

Planned document number

DIN EN ISO 11781

Project number

05702604

Responsible national committee

NA 057-01-04 AA - Genetically modified foodstuffs  

Responsible european committee

CEN/TC 275/WG 11 - Genetically modified foodstuffs  

Responsible international committee

ISO/TC 34/SC 16/WG 15 - Single laboratory validation of qualitative real time PCR  

draft standard

Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023); German and English version prEN ISO 11781:2023
2024-01
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previous edition(s)

Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Single-laboratory validation; German version CEN/TS 17329-1:2021
2021-09

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