Event-specific method for the detection of dried-killed bacterial biomass PT73 (TM) derived from E. coli GM strain AG3139 using real-time PCR : validation report and protocol

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a collaborative study to assess the performance of a qualitative event-specific method to detect the AG3139 transformation event in bacterial biomass derived from E. coli K-12 DNA. The collaborative trial was conducted according to internationally accepted guidelines (1, 2). In accordance with Regulation (EC) No 1829/2003 of 22 September 2003 "on genetically modified food and feed" and with Regulation (EC) No 641/2004 of 6 April 2004 "on detailed rules for the implementation of Regulation (EC) No 1829/2003", Ajinomoto Eurolysine S.A.S. provided the detection method and the samples (genomic DNA from E. coli K-12 harbouring the AG3139 event, bacterial biomass derived thereof, genomic DNA from the parental organism E. coli K-12 MG1655, and plasmids as positive and negative control samples). The JRC prepared the validation samples. The collaborative trial involved twelve laboratories from eight European countries. The results of the international collaborative trial met the ENGL performance requirements (see Annex 1). The method is, therefore, considered applicable to the control and feed samples provided, in accordance with the requirements of Annex I-2.C.2 to Commission Regulation (EC) No 641/2004. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.