ISO 20186-1:2019

Overview

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 guidance for the pre‑analytical handling of venous whole blood when the downstream goal is isolation and examination of cellular RNA. The standard focuses on the steps before the molecular test itself (collection, transport, storage, processing and documentation) to ensure blood cellular RNA profiles reflect the in vivo state rather than artifacts introduced after collection.

Key points:

• Applies to specimens collected in venous whole blood collection tubes.
• Intended for medical laboratories, laboratory customers, IVD developers and manufacturers, biobanks, research organizations and regulatory authorities.
• Excludes cell‑free circulating RNA, exosomal RNA, capillary/dried blood techniques, isolation of specific blood cell types, and pathogen RNA.

Key topics and requirements

ISO 20186-1 outlines practical pre‑examination controls and documentation, with clear normative language (e.g., shall = requirement, should = recommendation). Major technical topics covered include:

• Specimen collection
  • Information requirements about the donor/patient and specimen
  • Selection of appropriate venous whole blood collection tubes by the laboratory
  • Stabilization procedures during venepuncture
• Transport requirements
  • Conditions and documentation needed when moving samples from collection site to laboratory
• Inside‑laboratory processes
  • Specimen reception and traceability
  • Storage requirements for whole blood prior to RNA isolation
  • Isolation of cellular RNA, including guidance for:
    • Using collection tubes with RNA profile stabilizers
    • Using tubes without stabilizers (timing and handling considerations)
• RNA assessment and storage
  • Quantity and quality assessment of isolated cellular RNA
  • Storage recommendations for isolated RNA based on isolation method
• Supporting information
  • Annex A: Impact of pre‑examination steps on cellular RNA profiles
  • Annex B: Influence of storage temperature on blood cellular RNA

The standard references ISO 15189:2012 for laboratory quality and competence and is designed to support reproducible molecular IVD results.

Applications and who should use it

ISO 20186-1 is practical for organizations that need reliable, standardized pre‑analytical workflows for molecular diagnostics involving cellular RNA:

• Clinical and medical laboratories implementing RNA‑based assays
• IVD developers and manufacturers validating pre‑analytical device performance
• Biobanks and research institutions storing venous whole blood for RNA analysis
• Regulatory bodies and accreditation assessors reviewing pre‑examination procedures
• Laboratory customers and clinicians seeking specifications for sample collection and transport

Benefits include improved RNA integrity, reduced pre‑analytical variability, and stronger analytical traceability for molecular in vitro diagnostic examinations.

Related standards

• ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (normative reference)
• ISO 20186 series - other parts available on the ISO website detailing related pre‑analytical requirements

Keywords: ISO 20186-1:2019, pre-examination processes, venous whole blood, cellular RNA, molecular in vitro diagnostics, RNA stabilization, specimen collection, storage, transport, RNA quality.