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BS EN ISO 20813:2022:2023 Edition

$167.15

Foodstuffs. Principles of selection and criteria of validation for varietal identification methods using specific nucleic acid

Published By Publication Date Number of Pages
BSI 2023 34
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PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
8 4 Performance characteristics of the methods
4.1 General
4.2 Scope of the method
4.3 Scientific basis
4.4 Units of measurement
4.5 Applicability
9 4.6 Specificity
4.6.1 General
4.6.2 Requirements for inclusivity testing
4.6.3 Requirements for exclusivity testing
10 4.7 Sensitivity
4.7.1 General
4.7.2 Limit of detection (LOD)
11 4.8 Specific requirements for quantitative methods
4.8.1 General
4.8.2 Limit of quantification (LOQ)
4.8.3 Dynamic range
12 4.8.4 Determination of precision and trueness for quantitative methods
4.9 Robustness
4.9.1 General
4.9.2 Robustness determination by interlaboratory study
4.9.3 Robustness determination by a multifactorial orthogonal test design
5 Single-laboratory validation
13 6 Interlaboratory study (collaborative study)
6.1 General
6.2 Qualitative methods
6.3 Quantitative methods
7 General laboratory and procedural requirements
7.1 General
14 7.2 Facilities, materials and equipment
7.3 Sample preparation and DNA extraction
15 7.4 Use of controls
7.5 Data analysis
7.5.1 Control
16 7.5.2 Conventional PCR
7.5.3 Real-time PCR amplification curves
7.6 Expression of results
7.6.1 Expression of positive results
17 7.6.2 Expression of negative results
7.6.3 Expression of quantitative results
8 Test report
18 Annex A (informative) List of typical species used for inclusivity and exclusivity testing
23 Annex B (informative) Examples of unit conversion methods from DNA copy numbers to the ratio of masses
32 Bibliography
BS EN ISO 20813:2022
$167.15