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BS ISO 22949-1:2021

BS ISO 22949-1:2021

$142.49

Molecular biomarker analysis. Methods of analysis for the detection and identification of animal species in food and feed products (nucleotide sequencing-based methods) – General requirements

Published By Publication Date Number of Pages
BSI 2021 32
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This document specifies general requirements for DNA sequencing method performance in the detection and identification of animal species in food and feed products. Performance requirements are limited to Sanger and next generation sequencing (NGS), including second and third generation sequencing, for analysis of single species products and multispecies products.

This document is applicable to DNA sequences for mammals, birds, fish, molluscs, crustaceans, amphibians, reptiles and insects, and to the validation of the applicable methods.

Methods for DNA species quantification are not considered under the scope of this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
4 Performance characteristics of the methods
4.1 General
10 4.2 Fitness for purpose of the method
4.3 Scientific basis
4.3.1 General
4.3.2 Sanger sequencing
4.3.3 Next generation sequencing
11 4.4 Units of measurement
4.5 Applicability
4.5.1 Meat or food product considerations
4.5.2 Sampling plan
4.5.3 Genomic considerations
4.5.4 Method testing
12 4.6 Primer selection and evaluation
4.7 Database construction and evaluation
13 4.8 Selectivity and nucleotide sequence specificity
4.8.1 General
4.8.2 Requirements for inclusivity testing
4.8.3 Evaluation of non-targeted DNA interference
14 4.9 Sensitivity
4.9.1 General
4.9.2 Limit of detection
4.10 Robustness
4.10.1 General
4.10.2 Robustness determination by inter-laboratory study
15 4.10.3 Robustness determination by a multifactorial orthogonal test design
5 Single-laboratory validation
6 Interlaboratory study (collaborative study)
7 General laboratory and procedural requirements
7.1 General
16 7.2 Facilities, materials and equipment
7.3 Sample preparation
7.3.1 General
7.3.2 Category A: single species sample consisting of a single piece
17 7.3.3 Category B: single species product composed by several pieces or units of the same type of tissue
7.3.4 Category C: multiple mixed species processed product including those of non-meat origin or different types of tissues as ingredients
7.4 DNA extraction
18 7.5 DNA sequencing workflow
7.5.1 General
7.5.2 Sanger sequencing method
19 7.5.3 Next generation sequencing method
22 7.6 DNA sequence data analysis and interpretation
7.7 Expression of results
8 Validation of the NGS bioinformatics pipeline
8.1 General
8.2 Quality metrics
23 9 Test report
24 Annex A (informative) General workflow of the laboratory analytical procedure
25 Annex B (informative) Comparison between Sanger sequencing and next generation sequencing
26 Annex C (informative) In silico workflow for primer set selection
28 Bibliography

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BS ISO 22949-1:2021
$142.49