PD CEN/TS 16835-3:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated circulating cell free DNA from plasma
Hardcopy , PDF
27-11-2019
English
31-10-2015
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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) - Influence of isolation
procedures on ccfDNA fragments' lengths
distribution pattern in plasma samples
Bibliography
Specifies 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.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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.
| Standards | Relationship |
| CEN/TS 16835-3:2015 | 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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