CEN/TS 16835-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
12-03-2023
14-10-2015
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
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 |
CEN/TC 140
|
| DocumentType |
Technical Specification
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DIN CEN/TS 16835-2;DIN SPEC 13225-2:2015-12 | Identical |
| PD CEN/TS 16835-2:2015 | Identical |
| DIN SPEC 13225-2 : 2015 | Identical |
| NEN NVN CEN/TS 16835-2 : 2015 | Identical |
| UNI CEN/TS 16835-2 : 2015 | Identical |
| XP CEN/TS 16835-2 : 2015 XP | Identical |
| S.R. 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 |
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