Department Method Standardisation, Reference Laboratories, Resistance to Antibiotics, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany.
European Commission, Joint Research Centre (JRC), Ispra, Italy.
GM Crops Food. 2024 Dec 31;15(1):352-360. doi: 10.1080/21645698.2024.2423441. Epub 2024 Nov 14.
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.
根据现行的欧盟法规,转基因生物(GMO)及其衍生的食品和饲料产品必须作为转基因食品、饲料或种子获得授权,并且必须提供适当的检测方法,以便在官方控制中使用。Chhalliyil 等人最近发表了一种实时 PCR 方法,声称该方法专门用于检测和鉴定在北美商业化的基因组编辑油菜(OSR)品系。在之前的一项研究中,我们在三个参考实验室中独立评估了该方法的灵敏度、特异性和稳健性。我们发现该方法不符合欧盟 GMO 检测的所有最低性能要求(MPR),这与方法开发者的说法相矛盾。在这里,我们除了之前发表的方法评估研究之外,还表明修改后的 DNA 提取不是导致矛盾发现的原因,也不会影响方法的特异性。我们还讨论了方法开发者最近提出的用于解释高 Cq 值 PCR 结果的程序。