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  • BSI
    PD CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
    Edition: 2015
    $316.70
    / user per year

Description of PD CEN/TS 16835-3:2015 2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) 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 ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage. Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4]. Pathogen DNA present in blood is not covered by this Technical Specification.

Standard NumberPD CEN/TS 16835-3:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
StatusWithdrawn
Publication Date2015-10-31
Withdrawn Date2019-10-28
Replaced ByBS EN ISO 20186-3:2019
Identical National Standard OfCEN/TS 16835-3:2015
DescriptorsManagement, Quality assurance systems, Laboratory accreditation, Cells (biology), Quality assurance, Laboratory testing, Laboratories, Blood plasma, Quality, Medical laboratory equipment, Deoxyribonucleic acid, Medical sciences, Medical technology, Quality management
ICS11.100.30 Analysis of blood and urine
CommitteeCH/212
ISBN978 0 580 85027 1
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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