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].<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4 Principle 4.1 General 4.2 Preparation of seed\/grain groups <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.3 Detection methods for the qualitative analysis of GM seed\/grain in seed\/grain groups 4.4 Statistical evaluation <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5 Reagents 6 Apparatus and equipment 7 Design of testing plan 7.1 General 7.2 Single-stage testing plan <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 7.3 Double-stage testing plan <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 8 Selection of qualitative methods 8.1 General 8.2 Performance criteria 9 Interpretation <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 10 Expression of results 10.1 Classification of a seed\/grain lot into \u201caccept\u201d or \u201creject\u201d category 10.2 Estimation of the level of molecular biomarker in the seed\/grain lot 11 Test report <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Annex A (informative) Terms and definitions comparison table <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Annex B (informative) Implementation of the method to evaluate GMO content in seeds\/grains example <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex C (informative) Estimation of the limit of detection for a testing plan to detect GM seeds\/grains in seed lots <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex D (informative) Experimental determination of maximum group size <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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<\/b><\/p>\n |