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验证研究与能力验证测试

Validation studies and proficiency testing.

作者信息

Ankilam Elke, Heinze Petra, Kay Simon, Van den Eede Guy, Popping Bert

机构信息

European Commission, Joint Research Centre, Food Products Unit, Ispra, Italy.

出版信息

J AOAC Int. 2002 May-Jun;85(3):809-15.

PMID:12083280
Abstract

Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain <1% GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.

摘要

转基因生物(GMOs)于1996年进入欧洲食品市场。现行法规要求,如果食品产品含有低于1%的转基因成分(按产品的每种成分评估),则需对其进行标注。为增强对检测方法的信心并补充执法要求,迫切需要国际认可的方法,这些方法可作为参考方法。迄今为止,已有几种方法提交到国际层面的验证试验;现在存在可用于不同情况和不同食品基质的方法。此外,方法正式验证的要求已得到明确认可;几个国家和国际机构正积极组织相关研究。需要进行进一步的验证研究,尤其是针对定量聚合酶链反应方法,以满足对新提取方法、其他背景基质以及新型转基因生物构建体不断增长的需求。

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