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Molecular biomarker analysis - Method for the statistical evaluation of analytical results obtained in testing sub-sampled groups of genetically modified seeds and grains - General requirements
This document describes general requirements, procedures and performance criteria for evaluating the content of genetically modified (GM) seeds/grains in a lot by a group testing strategy that includes qualitative analysis of sub-sampled groups followed by statistical evaluation of the results.
This document is applicable to group testing strategy estimating the GM content on a percentage seed/grain basis for purity estimation, testing towards a given reject/accept criterion and for cases where seed/grain lots are carrying stacked events.
This document is not applicable to processed products.
NOTE Description of the use of group testing strategy are available in References [1], [7], [8], [18], [19] and [20].
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