PD CEN ISO/TS 7552-3:2024

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

1 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.