Title: In-house validation of an Event-specific Method for the Quantification of maize Bt176 using Real-time PCR
Authors: SAVINI CristianMAZZARA MarcoPINSKI GregorVAN DEN EEDE Guy
Publisher: Publications Office of the European Union
Publication Year: 2011
JRC Publication N°: JRC68068
ISBN: 978-92-79-22471-3
ISSN: 1831-9424
Other Identifiers: EUR 25130 EN
OPOCE LB-NA-25130-EN-N
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC68068
DOI: 10.2788/35536
Type: EUR - Scientific and Technical Research Reports
Abstract: The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house validation study to assess the performance of a quantitative event-specific method on the maize event Bt176 (unique identifier SYN-EV176-9). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Syngenta Crop Protection AG) provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at different GM percentages (DNA/DNA)]. The results of the in-house validation were evaluated with respect to method acceptance criteria and method performance requirements recommended by the European Network of GMO Laboratories (ENGL) (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm) and to its applicability in different real-time PCR instruments. The results obtained indicate that the method complies with the ENGL criteria. The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.
JRC Institute:Institute for Health and Consumer Protection

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