ISO 20186-1E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA
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.
This document is available in electronic format only.
Date of Publication: February 28, 2019
Order Code PDF: ISO201861E
Order Code Print: print not available
ISO 20186-1:2019 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.