Event-specific Method for the Quantification of Oilseed Rape MON88302 by Real-time PCR: Validation Report and Validated Method

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Event-specific Method for the Quantification of Oilseed Rape MON88302 by Real-time PCR: Validation Report and Validated Method
Abstract: 

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 polymerase chain reaction (PCR) method for detecting and quantifying oilseed rape event MON88302 (unique identifier MON-883?2-9). The validation study was conducted according to the EU-RL GMFF validation procedure [http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm] and the internationally accepted guidelines (1, 2). In accordance with current EU legislation , Monsanto has provided the detection method and the positive and negative control samples (genomic DNA extracted from seeds harbouring the MON-883?2-9 event as positive control DNA, genomic DNA extracted from seeds of conventional oilseed rape as negative control DNA). The EU-RL GMFF 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 according to Annex I-2.C.2 to Regulation (EC) No 641/2004 and it fulfils the analytical requirements of Regulation (EU) No 619/2011 .

Authors
Authors: 
SAVINI Cristian, PETRILLO Mauro, BOGNI Alessia, KREYSA Joachim, MAZZARA Marco
Publication Year
Publication Year: 
2013
Type

Type:

Appears in Collections
Appears in Collections: 
Institute for Health and Consumer Protection
Science Areas
JRC Institutes
Publisher
Publisher: 
Publications Office of the European Union
ISBN
ISBN: 
978-92-79-34892-1
ISSN
ISSN: 
1831-9424
DOI
URI
URI : 
Other Identifiers
Other Identifiers: 
EUR 26388
OPOCE LB-NA-26388-EN-N