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Collaborative trial validation of a testing plan for detection of low level presence of genetically modified seeds

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A testing plan for low level presence analysis of genetically modified (GM) seeds in non-GM seed lots based on a statistical approach is described. The plan is designed to estimate the presence of GM seeds at a test value of 0.1% and at a confidence level of 95%. Applying this testing plan, up to six subsamples of 1,000 seeds each are analysed by qualitative PCR in a two-step procedure. Based on calculations using the Seedcalc software, the number of GM positive PCR results obtained for this quantity of seeds and subsamples allows the estimation of whether the GM seed content in the inspected seed lot is above or below 0.1%.

The reliability of the testing plan was validated in two collaborative trials. Several maize or oilseed rape samples of 6,000 seeds were spiked with low levels of GM seeds and analysed by real-time PCR event-specific assays in 20 (maize) and 11 (rape) ISO 17025-accredited laboratories. The testing plan was successfully applied and enabled the participants to correctly estimate the presence of GM seeds at the 0.1% test value. No false-positive or false-negative results were reported for the samples. A comparison with results obtained by quantitative real-time PCR analysis for measurement of the GM maize seed content shows the subsampling approach to be superior.

The proposed two-step testing plan with a sample size of 6,000 seeds potentially enables laboratories to estimate seed samples at a value of 0.1% GM content with acceptable analysis efforts and costs.
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Document Type: Research Article

Publication date: December 1, 2014

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  • Seed Science and Technology (SST) is one of the leading international journals featuring original papers and review articles on seed quality and physiology as related to seed production, harvest, processing, sampling, storage, distribution and testing. This widely recognised journal is designed to meet the needs of researchers, advisers and all those involved in the improvement and technical control of seed quality.
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