Under current EU legislation, genetically modified organisms (GMOs) and derived food and feed products must be authorized as GM food, feed, or seed and appropriate detection methods must be made available for use in official controls. A Real-Time PCR method has recently been published by Chhalliyil et al. claiming to be specific for the detection and identification of genome-edited oilseed rape (OSR) lines commercialized in North America. In a previous study, we have independently assessed this method in three reference laboratories for sensitivity, specificity, and robustness. We found that the method does not meet all the minimum performance requirements (MPR) for GMO testing in the EU, which contradicts the claims of the method developer. Here we show, in addition to the previously published method assessment study that a modified DNA extraction is not the reason for the contradictory findings and does not affect the specificity of the method. We also discuss the procedures recently proposed by the method developers for interpreting PCR results with high Cq values.

中文翻译：

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DNA 提取是否会影响声称基因组编辑植物具有特异性可检测性的 PCR 方法的特异性？


根据现行欧盟立法，转基因生物 （GMO） 及其衍生食品和饲料商品必须被授权为转基因食品、饲料或种子，并且必须提供适当的检测方法用于官方控制。Chhalliyil 等人最近发表了一种实时 PCR 方法，声称该方法对检测和鉴定在北美商业化的基因组编辑油菜 （OSR） 品系具有特异性。在之前的一项研究中，我们在三个参考实验室独立评估了该方法的敏感性、特异性和稳健性。我们发现该方法并不符合欧盟 GMO 测试的所有最低性能要求 （MPR），这与方法开发商的说法相矛盾。在这里，除了先前发表的方法评估研究外，我们还表明，修饰的 DNA 提取不是导致矛盾结果的原因，也不会影响方法的特异性。我们还讨论了方法开发人员最近提出的用于解释具有高 Cq 值的 PCR 结果的程序。