PD CEN/TS 16835-2:2015
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

Standard No.

PD CEN/TS 16835-2:2015

Release Date

2015

Published By

European Committee for Standardization (CEN)

Latest

PD CEN/TS 16835-2:2015

Replace

FprCEN/TS 16835-2-2015

Scope

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures need to be taken for preserving blood circulating cell free DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification. DNA from pathogens present in blood is not covered by this Technical Specification.

PD CEN/TS 16835-2:2015 Referenced Document

• EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)*， 2024-04-20 Update
• EN ISO 22174:2005 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions
• ISO 15190:2003 Medical laboratories - Requirements for safety
• ISO Guide 30:2015 Reference materials - Selected terms and definitions

PD CEN/TS 16835-2:2015 history

• 2015 PD CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA