PD CEN/TS 16827-3:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 FFPE tissue Isolated DNA
Hardcopy , PDF
06-02-2019
English
31-08-2015
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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) - Impact of the storage temperature
on DNA Integrity in FFPE blocks of tissue
Bibliography
Provides recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA 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Superseded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 gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations [1], changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles [2]. These modifications of the DNA molecules can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA analysis.
| Standards | Relationship |
| CEN/TS 16827-3:2015 | 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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