Overview - ISO 20184-1:2018 (Frozen tissue - Isolated RNA)
ISO 20184-1:2018 provides standardized pre-examination guidance for handling, documenting, storing and processing frozen tissue specimens intended for RNA analysis in molecular in vitro diagnostic (IVD) workflows. The document addresses the entire pre-analytical phase - from specimen collection and transport to RNA isolation and storage of isolated RNA - and is applicable to medical laboratories, molecular pathology labs, biobanks, IVD developers, researchers and regulatory authorities. Note: tissues chemically stabilized before freezing are excluded.
Key technical topics and requirements
The standard structures the pre-examination process and defines requirements and recommendations using the conventional ISO verbs (“shall” = requirement, “should” = recommendation):
- Specimen collection and documentation
- Required information about the specimen donor/patient and about the specimen itself (collection metadata).
- Transport of fresh tissue
- Preparations and conditions for safe transport to the laboratory to minimise pre-analytical changes.
- Reception and sample selection
- Recording reception details and pathology evaluation to select representative frozen sample(s).
- Freezing and storage of tissue
- Procedures for freezing samples and storing frozen tissue to preserve RNA integrity (includes storage considerations and definitions such as room temperature = 18–25 °C).
- Isolation of RNA
- General requirements, recommendations, and options for using commercial kits or in‑house protocols; RNase control and prevention of degradation are emphasised.
- Quantity and quality assessment
- Guidance on assessing the amount and integrity of isolated RNA before analytical assays.
- Storage of isolated RNA
- Conditions and documentation for archiving extracted RNA for short- and long-term use.
- Definitions and pre-analytical vocabulary
- Key terms such as cold ischemia, warm ischemia, RNA profile, RNase and aliquot are defined for clarity.
- Informative annex
- Annex A discusses the impact of pre-examination variables (example: effects on RNA profiles from frozen liver tissue), illustrating practical effects of handling decisions.
Practical applications - who uses ISO 20184-1
- Clinical and molecular pathology laboratories implementing reliable RNA-based diagnostics.
- Biobanks and sample repositories standardizing frozen tissue handling for downstream RNA assays.
- IVD manufacturers and kit developers designing validated RNA extraction workflows and instructions for use.
- Biomedical researchers needing reproducible pre-analytical processes for transcriptomic studies.
- Regulatory bodies and quality managers ensuring compliance with robust pre-examination practices.
Related standards and cross-reference
- ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (referenced normative document).
- ISO 20184 series - other parts of the series are listed on the ISO website for complementary pre-examination guidance.
Keywords: ISO 20184-1:2018, pre-examination, frozen tissue, isolated RNA, RNA extraction, molecular in vitro diagnostic, pre-analytical workflow, molecular pathology, biobank, RNA quality.