Development and Evaluation of Event-Specific Qualitative PCR Methods for Genetically Modified Bt10 Maize
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文摘
In 2005 it was reported that the genetically modified (GM) maize strain or 'event' called Bt10 hadbeen distributed inadvertently in the United States over the previous 4 years. In order to ensure thatgrain for food and feed production did not contain trace amounts of Bt10 maize and complied withthe applicable regulation, highly sensitive and specific detection of Bt10 maize was required.Accordingly, we developed a novel qualitative PCR system for specific detection of Bt10 maize.Moreover, we amply evaluated the performance characteristics of two PCR systems, our own andthe one provided by the developer of Bt10, Syngenta Co. Ltd. It was confirmed that both of thequalitative PCR systems can specifically detect Bt10 maize, and the results of a single-laboratoryexamination suggested that the limit of detection was approximately less than 0.05% for both methods.To evaluate the reproducibility of the methods, we organized an interlaboratory study with theparticipation of 6 laboratories and analysis of 240 blind test samples. In this paper, we report, for thefirst time, the statistical analysis of the qualitative PCR data obtained from the interlaboratory study.The results of this analysis also revealed that there was no significant difference in the sensitivitybetween the two aforementioned methods and that the limit of detection of both the methods wasless than 0.05%. Thus, we conclude that both of the methods are equally suitable for correctidentification and sensitive detection of the unapproved GM maize Bt10 event in test samples.

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