SIST EN ISO 20186-3:2020 PDF

Overview

EN ISO 20186-3:2019 - "Molecular in‑vitro diagnostic examinations - Specifications for pre‑examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma" (CEN adoption of ISO 20186-3:2019) provides requirements and recommendations for the pre‑analytical (pre‑examination) handling, storage, processing and documentation of venous whole blood specimens intended for analysis of circulating cell free DNA (ccfDNA). The standard standardizes steps from specimen collection through plasma preparation and ccfDNA isolation to ensure reliable molecular in‑vitro diagnostic results and research data.

Key topics and technical requirements

• Specimen collection and documentation
  • Selection of appropriate venous whole blood collection tubes (with or without stabilizers) and required donor/patient information.
  • Procedures for venipuncture and tube selection communicated between collection sites and laboratories.
• Stabilization and limitations
  • Recommendations on measures for stabilizing ccfDNA in whole blood; explicitly excludes dedicated measures for blood genomic DNA (covered in ISO 20186‑2) and DNA in exosomes or pathogens.
• Transport and reception
  • Requirements for safe, documented transport and specimen reception before laboratory processing.
• Plasma preparation and storage
  • Procedures and storage requirements for preparing plasma from venous whole blood to minimize artefactual changes in ccfDNA quantity and fragmentation.
• Isolation of ccfDNA
  • Guidance for isolation workflows using tubes with stabilizers and without stabilizers, including considerations that pre‑analytical steps affect ccfDNA profiles.
• Quality and quantity assessment
  • Requirements for assessing isolated ccfDNA quality/quantity and for appropriate storage of isolated material.
• Traceability, documentation and quality systems
  • Emphasis on documenting pre‑examination steps to support reproducibility and compliance with laboratory quality systems.

Practical applications / Who should use this standard

• Medical laboratories performing molecular in‑vitro diagnostic tests targeting ccfDNA (liquid biopsy, oncology monitoring, prenatal testing).
• IVD developers and manufacturers designing blood collection devices, stabilizers, and ccfDNA extraction kits.
• Biobanks, research institutions and commercial biomedical researchers storing and processing plasma/ccfDNA samples.
• Regulatory authorities and accreditation bodies evaluating pre‑analytical quality for diagnostic assays.

Related standards

• ISO 20186 series (other parts cover different analytes and workflows) - ISO 20186‑2 covers blood genomic DNA.
• ISO 15189:2012 - medical laboratory quality and competence (normative reference).
• Supersedes CEN/TS 16835‑3:2015.

Keywords: EN ISO 20186-3:2019, ccfDNA, circulating cell free DNA, pre‑analytical, venous whole blood, plasma, molecular in‑vitro diagnostic, blood collection tubes, sample handling, pre‑examination processes.