Event-specific Method for the Quantification of Soybean MON87708 Using Real-time PCR - Validation Report and Validated Method
In line with its mandate the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), in collaboration with the European Network of GMO Laboratories (ENGL), has validated an event-specific real-time polymerase chain reaction (qPCR) method for detecting and quantifying the soybean event MON87708 (unique identifier MON-877Ø8-9). The validation study was conducted according to the EU-RL GMFF validation procedure [http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm] and the relevant internationally accepted guidelines.
In accordance with current EU legislation, Monsanto Company has provided the detection method and the positive and negative control samples (genomic DNA from soybean seeds harbouring the MON87708 event as positive control DNA, genomic DNA from conventional soybean seeds as negative control DNA). The EU-RL GMFF verified the method performance data provided by the developer, prepared the validation samples (calibration samples and blind samples at different GM percentage [DNA/DNA]), organised an international collaborative study and analysed the results.
The study confirms that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL and laid down in Annex I-2.C.2 to Regulation (EC) No 641/2004 and it fulfils the analytical requirements of Regulation (EU) No 619/2011.
This report is published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm.
SAVINI Cristian;
MAZZARA Marco;
MUNARO Barbara;
KREYSA Joachim;
2013-05-21
Publications Office of the European Union
JRC81896
978-92-79-29945-2,
1831-9424,
EUR 25982,
OP LB-NA-25982-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC81896,
10.2788/90943,
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