SIST EN ISO 20186-1:2019 PDF

Overview

EN ISO 20186-1:2019 (ISO 20186-1:2019) - Molecular in vitro diagnostic examinations - Specifications for pre‑examination processes for venous whole blood - Part 1: Isolated cellular RNA - provides standardized guidelines for the pre‑analytical phase of venous whole blood specimens intended for the isolation and analysis of blood cellular RNA. The standard covers handling, selection of venous blood collection tubes, stabilization options, transport, processing, storage and documentation for specimens collected in venous whole blood collection tubes. It expressly excludes cell‑free circulating RNA, exosomal RNA, capillary/dried blood methods, isolation of specific blood cell types, and pathogen RNA.

Key Topics and Requirements

• Specimen collection guidance
  • Information required about the donor/patient and lab selection of appropriate collection tubes.
  • Recommendations for collection technique and stabilization procedures.
• Selection of blood collection tubes
  • Use of tubes with or without blood cellular RNA profile stabilizers is addressed; different workflows apply depending on tube chemistry.
• Transport and storage
  • Requirements for specimen transport from collection site to laboratory and recommended storage conditions to minimize RNA profile changes.
• Laboratory reception and processing
  • Procedures for specimen reception, identification, and documentation consistent with ISO/quality practices.
  • Two main workflows for RNA isolation: using commercial kits and in‑house protocols; guidance on handling both.
• Quality assessment and storage of isolated RNA
  • Guidance on assessing RNA quantity and quality prior to downstream molecular in vitro diagnostic tests and on storage of isolated RNA.
• Informative annexes
  • Impact of pre‑examination steps on cellular RNA profiles and influence of storage temperature on RNA integrity.
• Normative reference
  • Links to laboratory quality and competence requirements (e.g., ISO 15189).

Applications and Who Uses This Standard

EN ISO 20186-1:2019 is intended for:

• Clinical and medical laboratories performing molecular in vitro diagnostic testing (molecular diagnostics).
• In vitro diagnostic (IVD) developers and manufacturers implementing robust pre‑analytical workflows.
• Biobanks, clinical trial sites and research institutions standardizing sample collection and storage.
• Regulatory authorities and quality managers for compliance and validation of pre‑analytical procedures.

Practical benefits include reduced pre‑analytical variability, improved RNA integrity for reliable downstream assays (qPCR, NGS, transcriptomics), reproducible SOPs, and strengthened regulatory and accreditation submissions.

Related Standards

• ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (normative reference).
• EN ISO 20186 series - other parts cover different analytes or specimen types (see ISO website for the full list).
• Supersedes CEN/TS 16835‑1:2015 (adopted by CEN as EN ISO 20186‑1:2019).