Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
Abstract
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed and/or developed by medical laboratories, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research. It is also intended to be used by laboratory customers including health institutions requesting examinations for their patients as well as biobanks and regulatory authorities. This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA. This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. fetal cells). NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Begin
2022-12-14
WI
00140154
Planned document number
DIN CEN ISO/TS 7552-2
Project number
06302192
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Responsible international committee
ISO/TC 212/WG 4 - Microbiology and molecular diagnostics
