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ISO 20186-2E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA

ISO 20186-2:2019

ISO 20186-2E 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.

This document is available in electronic format only.

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Details

Date of Publication: February 28, 2019

Order Code PDF: ISO201862E

Order Code Print: print not available

Edition: First

Pages: 20

ISO 20186-2:2019 Additional Details

Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.