BS ISO 20813:2019

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Molecular biomarker analysis. Methods of analysis for the detection and identification of animal species in foods and food products (nucleic acid-based methods). General requirements and definitions

Published By	Publication Date	Number of Pages
BSI	2019	34

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Description

This document specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA) by molecular methods, such as the polymerase chain reaction (PCR), including different post-PCR detection methods, real-time PCR, single and/or multiple probe-based detection techniques as well as the combination of such methods.

The document is applicable to the detection, identification and quantification of DNA from animal species of higher and lower taxonomic groups in foodstuffs, and the validation of applicable methods.

It is applicable to mammals, birds, reptiles, amphibians, fishes, molluscs, crustaceans and insects. Typical examples for each are listed in Annex A.

PDF Catalog

PDF Pages	PDF Title
2	National foreword
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

Additional information

Status	Withdrawn
Pages	34
Publication Date	2019-05-13
Withdrawn Date	2023-03-21
ISBN	978 0 580 96037 6
Standard Number	BS ISO 20813:2019
Title	Molecular biomarker analysis. Methods of analysis for the detection and identification of animal species in foods and food products (nucleic acid-based methods). General requirements and definitions
Identical National Standard Of	ISO 20813
Descriptors	Food control, Food, Testing methods, Testing (programs), Testing
Publisher	BSI
Committee	AW/275
ICS Codes	67.050 - General methods of tests and analysis for food products

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BS ISO 20813:2019

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