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Report on the single-laboratory validation of a PCR-based Detection Method for Identification of Florigene™ IFD-25958-3 GM Carnation -Validation Report and Validated Method

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In the context of the application for marketing submitted by Florigene Pty Ltd for a genetically modified carnation line (C/NL/09/01) IFD-25958-3, the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF) has carried out a single-laboratory validation to assess the performance of a polymerase chain reaction (PCR)-based detection method for detecting and identifying the carnation GM line IFD-25958-3. This report describes the results of tests carried out by the EU-RL GMFF on control samples provided by the method developer and according to the detection method described by the applicant. The taxon-specific method correctly detects the endogenous gene target in genomic DNA of a conventional carnation line (negative control) and in the genomic DNA of the GM carnation line; the same method can also detect the GM target DNA in IFD-25958-3 GM line (positive control) in the experimental conditions described in this report. The Limit of Detection (LOD) of the method has been estimated to be at least 50 copies for the taxon-specific gene and at least 100 copies for the GM insert, based on haploid genome copy number.
2013-01-11
Publications Office of the European Union
JRC77720
978-92-79-28077-1,   
1831-9424,   
EUR 25679,    OP LB-NA-25679-EN-N,   
https://publications.jrc.ec.europa.eu/repository/handle/JRC77720,   
10.2788/76760,   
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