Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing – part 2
European Network of GMO Laboratories
European Union Reference Laboratory for Genetically Modified Food and Feed
The document “Definition of Minimum Performance Requirements for analytical methods of GMO testing” (ENGL 2015) is a guidance developed by the ENGL and the EU Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). It supports the development and validation of methods for GMO analysis submitted in the frame of applications for EU market authorisation of GMO products and to be used also in the official control of food and feed. The guidance document provides definitions and requirements for the assessment of performance parameters of methods developed for the detection and quantification of GMOs based on real-time PCR.
More recently, technologies like digital PCR were successfully applied in various fields for the quantification of nucleic acid molecules, including GMOs. Moreover, GM animals and products developed by means of so-called new genomic techniques (Broothaerts et al. 2021) are approaching the market and have characteristics different from GM plant products.
Therefore, ENGL experts have extended the original method performance parameters for guiding users in the validation of digital PCR methods for GMO analysis.
Specific recommendations are also provided for methods developed for the detection of DNA of GM animals in food and feed products and for products characterised by small DNA sequence alterations generated by new genomic techniques.
GATTO Francesco;
SAVINI Cristian;
BAILLIE Christin-Kirsty;
BROOTHAERTS Wim;
BURNS Malcolm;
DAGAND Emilie;
DEBODE Frédéric;
DOBNIK David;
GRANTIŅA-IEVIŅA Lelde;
GROHMANN Lutz;
LIESKE Kathrin;
MARCHESI Ugo;
MARIEN Aline;
MAZZARA Marco;
PAPAZOVA Nina;
VAN DER BERG Jan Pieter;
VERGINELLI Daniela;
ZDEŇKOVÁ Kamila;
2023-04-11
Publications Office of the European Union
JRC125975
978-92-68-01745-6 (online),
1831-9424 (online),
EUR 31470 EN,
OP KJ-NA-31-470-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC125975,
10.2760/63656 (online),
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