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BS ISO 22942-1:2022

BS ISO 22942-1:2022

$189.07

Molecular biomarker analysis. Isothermal polymerase chain reaction (isoPCR) methods – General requirements

Published By Publication Date Number of Pages
BSI 2022 50
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Principle
5 Development of an isoPCR method
5.1 General
5.2 Intended purpose
5.3 Scientific basis
14 5.4 Units of measurement
5.5 Method validation
5.6 Performance criteria
5.6.1 General
5.6.2 Sensitivity
15 5.6.3 Nucleic acid extract quality
5.6.4 Applicability
5.6.5 Nucleic acid sequence specificity
5.6.6 Precision
16 5.6.7 Accuracy
5.6.8 Selectivity
5.6.9 Linearity
5.6.10 Limit of detection (LOD)
17 5.6.11 Limit of quantification (LOQ)
18 5.6.12 Range
5.6.13 Robustness
19 6 General laboratory and procedural requirements
6.1 Competence
6.2 Sample preparation
6.2.1 General
6.2.2 Obtaining a representative sample
6.2.3 Preparation of the test portion
20 6.2.4 Nucleic acid extraction
6.3 Use of controls
6.3.1 General
6.3.2 Environmental controls
6.3.3 Positive controls
6.3.4 Negative controls
6.3.5 Extraction controls
21 6.4 Workspace organization
6.4.1 General
6.4.2 Design of the workspace — Laboratory design
6.4.3 Design of non-laboratory workspaces
6.4.4 Personnel
22 6.4.5 Apparatus and equipment
7 Materials and reagents
8 Interpretation of results
8.1 General
8.2 Interpretation of controls
23 8.3 Expression of results
8.3.1 General
8.3.2 Expression of a negative result
24 8.3.3 Expression of a positive result
8.3.4 Expression of quantitative results
8.3.5 Expression of ambiguous results
9 Test report
26 Annex A (informative) Minimum information for an isoPCR experiment (MIIPCRE)
29 Annex B (normative) Use of controls
30 Annex C (informative) Examples of isothermal nucleic acid isoPCR amplification results
31 Annex D (informative) Loop mediated isothermal amplification (LAMP)
34 Annex E (informative) Rolling circle amplification (RCA)
35 Annex F (informative) Helicase dependent amplification (HDA)
37 Annex G (informative) Recombinase polymerase amplification (RPA)
39 Annex H (informative) Strand displacement amplification (SDA)
41 Annex I (informative) Nucleic acid sequence based amplification (NASBA)
44 Annex J (informative) Cas9nAR amplification
46 Bibliography

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BS ISO 22942-1:2022
$189.07