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  

previous edition(s)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA; German version CEN/TS 17390-2:2020
2020-05

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