What is PD CEN/TS 17390‑1 about?
PD CEN/TS 17390 discusses Molecular in vitro diagnostic examinations. PD CEN/TS 17390‑1 lays out guidelines on the handling, storage, processing, and documentation of human venous whole blood specimens intended for the examination of RNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.
The requirements given in PD CEN/TS 17390‑1 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 this document.
Note 1: PD CEN/TS 17390‑1 does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood – Part 1: Isolated cellular RNA.
Note 2: PD CEN/TS 17390‑1 does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom.
Note 3: PD CEN/TS 17390‑1 does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Who is PD CEN/TS 17390‑1 for?
PD CEN/TS 17390‑1 on human RNA isolated from CTCs during the pre-examination processes is useful for:
- Biomedical laboratories
- In vitro diagnostic centres
- Regulatory authorities
Why should you use PD CEN/TS 17390‑1?
Solid tumours release cells and bioanalyses into the blood and other body fluids. This has opened the option of minimally invasive tumour detection, diagnosis, and characterization from venous whole blood (liquid biopsies). Liquid biopsies are expected to enable earlier detection, diagnosis of cancers, and advance personalized patient treatment. These applications have become one of the fastest-growing segments of the entire diagnostic market.
PD CEN/TS 17390‑1 guideline helps you with 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 RNA isolated from CTCs during the pre-examination processes. This helps in proper assessment and ensures results are reliable and can be reproduced for human RNA isolated from circulating tumour cells (CTCs) in venous whole blood.