Event-specific Method for the Quantification of Soybean DAS-68416-4 Using Real-time PCR: Validation report

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Event-specific Method for the Quantification of Soybean DAS-68416-4 Using Real-time PCR: Validation report
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 soybean event DAS-68416-4 (unique identifier DAS-68416-4). The validation study was conducted according to the EU-RL GMFF validation procedure (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and internationally accepted guidelines. In accordance with current EU legislation , Dow AgroSciences LLC provided the detection method and the positive and negative control samples (genomic DNA extracted from soybean kernels harbouring the DAS-68416-4 event as positive control DNA, genomic DNA extracted from conventional soybean kernels 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: 
KREYSA Joachim, MAZZARA Marco, SAVINI Cristian, SACCO Maria-Grazia
Publication Year
Publication Year: 
2014
Type

Type:

Appears in Collections
Appears in Collections: 
Institute for Health and Consumer Protection
JRC Institutes
Publisher
Publisher: 
Publications Office of the European Union
ISBN
ISBN: 
978-92-79-38870-5
ISSN
ISSN: 
1831-9424
DOI
URI
URI : 
Other Identifiers
Other Identifiers: 
EUR 26706
OPOCE LB-NA-26706-EN-N