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Single-laboratory validation of a method for detection of Roundup Ready soy in soybeans: application of new strategies for qualitative validation

机译：Single-laboratory验证的方法检测抗农达大豆在大豆:应用定性的新策略验证

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Considering expansion of genetically modified organisms and the basic principle of consumers' right to access information about products, legislations of several countries establish a limit for labelling transgenic food. Qualitative tests based on the polymerase chain reaction (PCR) have been recommended. However, validation of qualitative methods is still a critical point in the quality management of food analysis laboratories. A screening method for the detection of Roundup Ready (RR) soy in soybeans by nested PCR was validated by a novel qualitative approach, in a single-laboratory, considering all fundamental parameters for an adequate evaluation of fitness for purpose. Blank samples of soybeans and formulations containing 0.001 to 1% of RR soy were analysed. Agarose gel electrophoresis and fluorimetry techniques were compared in terms of the quantification of extracted DNA. False-positive rate obtained was 0%, with selectivity and reliability rates of 100.0% for both techniques. Sensitivity and reliability rates varied between 23.3 and 100.0% (agarose gel) and between 30.0 and 100.0% (fluorimetry), respectively. Levels above 0.030% presented 100.0% positive results. Unreliable regions were estimated by non-linear models, and the calculated detection limits were 0.0067 and 0.0047%, for agarose gel electrophoresis and fluorimetry, respectively. Accordance and concordance values of 1.0 were obtained for levels near the regulated limit. The method was considered fit for screening purposes. Analysis of commercial samples demonstrated the applicability of the method and the compliance with Brazilian legislation.
机译：考虑转基因的扩张生物和消费者的基本原理有权访问产品信息,建立一个立法的几个国家限制对转基因食品贴标签。基于聚合酶链反应测试(PCR)已推荐。定性的方法仍然是一个临界点食品质量管理的分析实验室。检测抗农达大豆在大豆(RR)通过嵌套PCR验证了一部小说single-laboratory定性方法,,考虑所有的基本参数足够的适用性评价。大豆和配方包含的样本0.001到1%的抗农达大豆进行分析。电泳和荧光分析技术比较的量化提取DNA。率0%,选择性和可靠性这两种技术为100.0%。可靠性利率变化在100.0%和23.3之间(琼脂糖凝胶)和在100.0%和30.0之间分别(荧光)。提出了100.0%的积极成果。区域估计的非线性模型,计算检测极限是0.00670.0047%琼脂糖凝胶电泳分别荧光测定法。和合1.0得到的值水平附近的监管限制。他们认为适合筛选的目的。商业展示了样品方法的适用性和遵从性与巴西立法。

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