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ISO/TS 7552-3:2024

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC staining
4 nën 2024

General information

60.60     4 nën 2024

ISO

ISO/TC 212

Technical Specification

11.100.10  

anglisht  

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Scope

This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination 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 pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.
NOTE 1        The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2        International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Life cycle

NOW

PUBLISHED
ISO/TS 7552-3:2024
60.60 Standard published
4 nën 2024

National adoptions

Ekzaminime molekulare për diagnostikimin in vitro - Specifikimet për proceset e paraekzaminimit për qelizat tumorale qarkulluese (CTC) në venat e gjakut - Pjesa 3: Preparate për ngjyrosjen analitike të qelizave tumorale CTC

40.20 DIS ballot initiated: 12 weeks

DPS/KT 140 më tepër