Real-Time PCR-Based Ready-to-Use Multi-Target Analytical System for GMO Detection

This paper describes the development, production, and testing of a high-throughput analytical system, i.e., a unique screening tool for the unequivocal simultaneous identification of all currently EU-approved and all unapproved genetically modified organisms (GMOs) known to the Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established according to Regulation (EC) No 1829/2003. The rationale and comparative advantage of the strategy selected as well as the formulation, potentiality, and flexibility of the system are illustrated here. The approach, developed in response to the worldwide growing testing needs, allows the event-specific simultaneous detection of 39 single-insert GMOs and their derived stacked events. System performance (specificity, efficiency, etc) has been successfully confirmed by experimental testing conducted within the CRL-GMFF and in collaboration with European control laboratories. The limit of detection (LOD) has been determined to be at least 0.045% expressed in haploid genome copies, thus in full compliance with EU requirements for method LOD. The "real-time PCR-based ready-to-use multi-target analytical system for GMO detection" developed by the Joint Research Centre is the first analytical tool worldwide allowing the simultaneous detection of so many genetic modification events using event-specific targets