PD CEN/TS 17390 discusses Molecular in vitro diagnostic examinations. PD CEN/TS 17390‑2 lays out 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.
The requirements given in PD CEN/TS 17390‑2 can also be applied to other circulating rare cells (e.g., foetal cells). International, national, or regional regulations or requirements can also apply to specific topics covered in PD CEN/TS 17390‑2.
Note 1: PD CEN/TS 17390-2 does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA.
Note 2: PD CEN/TS 17390‑2 does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom.
Note 3: PD CEN/TS 17390‑2 does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
PD CEN/TS 17390‑2 on human DNA isolated from CTCs during the pre-examination processes is useful for:
Circulating tumour cells (CTCs) in venous whole blood reflect the disease complexity that evolves during tumour progression, with distinct genetic, epigenetic and expression features. Besides the prognostic role of CTC identification and/or enumeration in cancer progression, CTC molecular characterization can improve e.g., disease outcome prediction, therapeutic guidance, and post-treatment monitoring of the patient.
PD CEN/TS 17390-2 guideline provides General considerations, Specimen collection, Transport requirements, Inside/outside the laboratory, Specimen reception, Enrichment of CTCs, Quality of enriched CTCs, Processing of isolated CTCs, Storage of isolated RNA from enriched CTCs, Quantity, and quality assessment of isolated RNA from enriched or isolated CTCs for human DNA isolated from CTCs during the pre-examination processes. This helps in proper assessment and ensures results are reliable and can be reproduced for human DNA isolated from circulating CTCs in venous whole blood.
CEN/TS 17390-2:2020