BSI PD CEN/TS 17329-2:2019
$142.49
Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods – Collaborative study
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 26 |
This document provides information on how the performance characteristics of qualitative (binary) real-time polymerase chain reaction (PCR) methods for detection of specific DNA sequences present in foods should be evaluated and validated by conducting a collaborative study.
The guidelines are applicable for validation of qualitative PCR methods used for detection of DNA sequences derived from genetically modified foodstuffs. They can be applicable also for PCR methods used for detection of other target sequences in foodstuffs, e.g. for species detection and identification.
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 Validation of the performance characteristics by means of a collaborative study 5.1 General |
| 9 | 5.2 False-positive rate and false-negative rate 5.2.1 General 5.2.2 Procedure with DNA as collaborative study test samples 5.2.3 Procedure with food material as collaborative study test samples |
| 10 | 5.2.4 Evaluation and performance criteria 5.3 Robustness 5.4 Probability of detection (POD) 5.4.1 General |
| 11 | 5.4.2 Preparation of concentration levels 5.4.3 Number of PCR replicates per laboratory 5.4.4 Evaluation of POD data |
| 12 | 5.4.5 Performance criteria for the POD curve 6 Calculation of precision data for test samples 7 Study report |
| 14 | Annex A (informative) Instructions for the conduct of the collaborative study |
| 21 | Annex B (informative) Statistical model |
| 25 | Bibliography |
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