Abstract
Quantification of genetically modified organisms (GMOs) in food and feed products is often required for their labelling or for tolerance thresholds. Standard-curve-based simplex quantitative polymerase chain reaction (qPCR) is the prevailing technology, which is often combined with screening analysis. With the rapidly growing number of GMOs on the world market, qPCR analysis becomes laborious and expensive. Innovative cost-effective approaches are therefore urgently needed. Here, we report the development and inter-laboratory assessment of multiplex assays to quantify GMO soybean using droplet digital PCR (ddPCR). The assays were developed to facilitate testing of foods and feed for compliance with current GMO regulations in the European Union (EU). Within the EU, the threshold for labelling is 0.9% for authorised GMOs per ingredient. Furthermore, the EU has set a technical zero tolerance limit of 0.1% for certain unauthorised GMOs. The novel multiplex ddPCR assays developed target 11 GMO soybean lines that are currently authorised, and four that are tolerated, pending authorisation in the EU. Potential significant improvements in cost efficiency are demonstrated. Performance was assessed for the critical parameters, including limits of detection and quantification, and trueness, repeatability, and robustness. Inter-laboratory performance was also determined on a number of proficiency programme and real-life samples.
Highlights
Quantification of genetically modified organisms (GMOs) in food and feed products is often required for their labelling or for tolerance thresholds
A consequence of this threshold is that distinction between authorised and unauthorised GMOs is required, and sensitive and specific detection and quantification methods are needed
European Union (EU) legislation requires that methods for detection and quantification of both the reference gene and the specific GM-event sequence are provided by the applicant for GMO authorisation[7]
Summary
Quantification of genetically modified organisms (GMOs) in food and feed products is often required for their labelling or for tolerance thresholds. EU legislation requires that methods for detection and quantification of both the reference gene and the specific GM-event sequence are provided by the applicant for GMO authorisation[7]. This includes the funding for validation of the method by the EU Reference Laboratory for GM Food and Feed (EURL-GMFF), assisted by the European Network of GMO Laboratories (ENGL). The labelling required is based on the total concentration of GM-events per ingredient, with an ingredient in this context interpreted as a species[8] This opens the possibility to take a different approach, in which all GMOs from a species can be quantified simultaneously using one fluorophore[8]
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