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BSI PD ISO/TS 4425:2023

BSI PD ISO/TS 4425:2023

$142.49

Genomics informatics. Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing

Published By Publication Date Number of Pages
BSI 2023 30
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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
13 4 Abbreviated terms
5 Microsatellite instability (MSI)
14 6 Composition of elements for describing MSI status on clinical DNA NGS report
6.1 General
15 6.2 Summary part
6.3 Detail part
7 Fields and their nomenclature of required data
7.1 General
16 7.2 Clinical sequencing order
7.2.1 General
7.2.2 Clinical sequencing order code
7.2.3 Date and time
17 7.3 Information on subject of care
7.3.1 General
7.3.2 Subject of care identifier
7.3.3 Subject of care name
7.3.4 Subject of care birth date
7.3.5 Subject of care sex
7.3.6 Subject of care ancestry
18 7.3.7 Referring diagnosis
7.4 Information on legally authorized person ordering clinical sequencing
7.4.1 General
7.5 Performing laboratory
7.5.1 General
7.5.2 Basic information on performing laboratory
7.5.3 Information on report generator
7.5.4 Information of legally confirmed person on sequencing report
7.6 Biospecimen information
7.6.1 General
7.6.2 Type of specimen
19 7.7 MSI status result information
7.7.1 General
7.7.2 MSI status
7.8 Recommended treatment
7.8.1 General
7.8.2 Medication
7.8.3 Clinical trial information
7.8.4 Other recommendations
7.8.5 Supporting information
20 8 Fields and their nomenclature of optional data
8.1 General
8.2 Reference genome information
21 8.3 MSI information
8.3.1 General
8.3.2 Criteria of MSI status
8.3.3 Genomic position for determining MSI status
8.3.4 Genomic position against markers of alternative method
8.3.5 Clinical implication of MSI status
8.4 Sequencing information
8.4.1 Clinical sequencing date
8.4.2 Sequencing type
22 8.4.3 Quality control metrics
8.4.4 Sequencing platform information
8.4.5 Analysis platform information
24 Annex A (informative) Example structure of MSI status report
27 Bibliography

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BSI PD ISO/TS 4425:2023
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