BSI PD CEN/TS 17329-1:2019
$102.76
Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods – Single-laboratory validation
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 22 |
This document describes the performance characteristics and minimum performance criteria which should be taken into account when 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.
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.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 5 | European foreword |
| 6 | Introduction |
| 7 | 1 Scope 2 Normative references 3 Terms and definitions |
| 8 | 4 Principle 5 Single-laboratory validation of the performance characteristics 5.1 General 5.2 Limit of detection (LOD95 %) |
| 9 | 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 % |
| 10 | 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 |
| 11 | 6 Validation report |
| 12 | Annex A (informative) Estimation of the number of copies of the target sequence |
| 14 | Annex B (informative) Determination of limit of detection, precision and PCR efficiency |
| 17 | Annex C (informative) Statistical Model |
| 20 | Annex D (informative) Robustness testing |
| 21 | Bibliography |
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