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BS EN ISO 20186-1:2019

BS EN ISO 20186-1:2019

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood – Isolated cellular RNA

Published By Publication Date Number of Pages
BSI 2019 30
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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA 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 RNA and RNA in exosomes circulating in blood. These are not described in this document.

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 cellular RNA therefrom.

RNA in pathogens present in blood is not covered by this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 General considerations
14 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
15 5.1.4 Information about the specimen and storage requirements at the blood collection facility
16 5.2 Transport requirements
6 Inside the laboratory
6.1 Specimen reception
6.2 Storage requirements
17 6.3 Isolation of the cellular RNA
6.3.1 General
6.3.2 Using blood collection tubes with RNA profile stabilizers
6.3.3 Using blood collection tubes without RNA profile stabilizers
18 6.4 Quantity and quality assessment of isolated cellular RNA
19 6.5 Storage of isolated cellular RNA
6.5.1 General
6.5.2 Cellular RNA isolated with commercially available kits
6.5.3 Cellular RNA isolated with the laboratory’s own protocols
20 Annex A (informative) Impact of pre-examination process steps on venous whole blood cellular RNA profiles
24 Annex B (informative) Influence of blood storage temperature on blood cellular RNA profiles
27 Bibliography

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BS EN ISO 20186-1:2019
$142.49