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Normas BSI – AENOR
PD CEN/TS 16827-3:2015

PD CEN/TS 16827-3:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated DNA

Fecha Anulación:
2019-01-28 /Withdrawn
Comité:
CH/212
Equivalencias internacionales:

CEN/TS 16827-3:2015

Relación con otras normas BSI:

Reemplazada por: BS EN ISO 20166-3:2019

Resumen:
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.
Keywords:
Medical technology, Laboratories, Laboratory testing, Quality assurance systems, Quality, Management, Quality management, Medical sciences, Medical laboratory equipment, Laboratory accreditation, Quality assurance
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