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BSI PD CEN/TS 17390-3:2020

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Preparations for analytical CTC staining
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BSI PD CEN/TS 17390-3:2020

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Preparations for analytical CTC staining

PUBLISH DATE 2020
PAGES 22
BSI PD CEN/TS 17390-3:2020

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the **CTC (Circulating Tumor Cell) enrichment**, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories.

It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

This document does not cover specific staining procedures.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

SDO BSI: British Standards Institution
Document Number CEN/TS 17390-3
Publication Date Jan. 24, 2020
Language en - English
Page Count 22
Revision Level
Supercedes
Committee CH/212
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