What is PD CEN/TS 17390‑3 about?
PD CEN/TS 17390 discusses Molecular in vitro diagnostic examinations. PD CEN/TS 17390‑3 outlines guidelines on the handling, storage, processing, and documentation of human venous whole blood specimens intended for staining of circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.
PD CEN/TS 17390-3 describes measures to standardize the pre-examination process to obtain appropriate CTC staining.
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 PD CEN/TS 17390-3
Note 3: PD CEN/TS 17390-3 does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Who is PD CEN/TS 17390‑3 for?
PD CEN/TS 17390‑3 on Preparations for analytical CTC staining is useful for:
- Biomedical laboratories
- In vitro diagnostic centres
- Regulatory authorities
Why should you use PD CEN/TS 17390‑3?
Solid tumours release cells and bioanalytic 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 and diagnosis of cancers and advance personalized patient treatment.
PD CEN/TS 17390-3 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 Preparations for analytical CTC staining. This helps in proper assessment and ensures results are reliable and can be reproduced for Preparations for analytical CTC staining.