ISO 20186-2:2019
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document.
NOTE Circulating cell free DNA in blood is covered in ISO 20186-3.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
5.1 Specimen collection
5.1.1 Information about the specimen donor/patient
5.1.2 Selection of the venous whole blood collection tube by the laboratory
5.1.3 Venous whole blood specimen collection from the donor/patient and stabilization procedures
5.1.4 Information about the specimen and storage requirements at the blood collection facility
5.2 Transport requirements
6 Inside the laboratory
6.1 Specimen reception
6.2 Storage requirements
6.3 Isolation of the genomic DNA
6.3.1 General
6.3.2 Examination provider's instructions available
6.3.3 Examination provider's instructions not available
6.4 Quantity and quality assessment of isolated genomic DNA
6.5 Storage of isolated genomic DNA
6.5.1 General
6.5.2 Genomic DNA isolated with commercially available kits
6.5.3 Genomic DNA isolated with the laboratory's own protocols
Annex A (informative) Impact of pre-examination process steps on venous whole blood genomic DNA quality
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
5.1 Specimen collection
5.1.1 Information about the specimen donor/patient
5.1.2 Selection of the venous whole blood collection tube by the laboratory
5.1.3 Venous whole blood specimen collection from the donor/patient and stabilization procedures
5.1.4 Information about the specimen and storage requirements at the blood collection facility
5.2 Transport requirements
6 Inside the laboratory
6.1 Specimen reception
6.2 Storage requirements
6.3 Isolation of the genomic DNA
6.3.1 General
6.3.2 Examination provider's instructions available
6.3.3 Examination provider's instructions not available
6.4 Quantity and quality assessment of isolated genomic DNA
6.5 Storage of isolated genomic DNA
6.5.1 General
6.5.2 Genomic DNA isolated with commercially available kits
6.5.3 Genomic DNA isolated with the laboratory's own protocols
Annex A (informative) Impact of pre-examination process steps on venous whole blood genomic DNA quality
Bibliography