• There are no items in your cart

PD CEN/TS 16835-2:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated genomic DNA
Available format(s)

Hardcopy , PDF

Superseded date

05-10-2019

Language(s)

English

Published date

10-31-2015

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
6 Inside the laboratory
Annex A (informative) - Impact of preanalytical
        workflow steps on venous whole blood
        genomic DNA quality
Bibliography

Specifies 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 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 cell free circulating 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. Pathogen DNA present in blood is not covered by this Technical Specification.

Committee
CH/212
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
CEN/TS 16835-2:2015 Identical

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 15189:2012 Medical laboratories — Requirements for quality and competence
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 22174:2005)
ISO 15190:2003 Medical laboratories Requirements for safety
ISO Guide 30:2015 Reference materials Selected terms and definitions

View more information
US$237.18
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.