{"id":375949,"date":"2024-10-20T02:46:00","date_gmt":"2024-10-20T02:46:00","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-cen-ts-17329-12021\/"},"modified":"2024-10-26T04:51:37","modified_gmt":"2024-10-26T04:51:37","slug":"bsi-pd-cen-ts-17329-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-cen-ts-17329-12021\/","title":{"rendered":"BSI PD CEN\/TS 17329-1:2021"},"content":{"rendered":"
This document describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.<\/p>\n
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.<\/p>\n
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | 4 Principle 5 Single-laboratory validation of the performance characteristics 5.1 General 5.2 Limit of detection (LOD95 %) <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 5.3 Evaluation of data for the limit of detection (LOD95 %) 5.4 PCR efficiency and variability of the measured copy number around the LOD95 % <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 5.5 Specificity 5.5.1 General 5.5.2 Theoretical test for specificity 5.5.3 Practical test for specificity 5.5.4 Robustness <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 6 Validation report <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Annex A (informative) Estimation of the number of copies of the target sequence <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | Annex B (informative) Determination of limit of detection, precision and PCR efficiency <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | Annex C (informative) Statistical Model <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Annex D (informative) Robustness testing <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods – Single-laboratory validation<\/b><\/p>\n |