Overview
ISO 20184-2:2018 - "Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins" provides standardized guidance for the pre-examination handling of frozen tissue when the intended downstream assay analyzes isolated proteins. The standard covers the chronology from specimen collection and transport through laboratory reception, freezing, protein isolation, quality/quantity assessment and storage of both frozen tissue and isolated protein analytes. It is explicitly intended for molecular in vitro diagnostic workflows and excludes chemically stabilized tissues and immunohistochemistry.
Key topics and requirements
- Pre-examination workflow: Defines steps that start with the clinical request and end when the analytical assay begins, emphasizing traceability and documented procedures.
- Specimen collection & transport: Guidance on information to capture about the donor/patient and specimen, and precautions to minimize pre-analytical changes (e.g., effects of warm and cold ischemia).
- Reception and pathology evaluation: Requirements for recording specimen reception, pathology assessment and selection of appropriate sample(s) for protein isolation.
- Freezing and storage: Procedures and documentation for freezing tissue and for the storage and long-term archiving of tissue and isolated proteins to preserve protein integrity and stability.
- Protein isolation: Recommendations on isolating total protein using commercial kits or laboratory-developed protocols, including validation/verification considerations.
- Quality and quantity assessment: Requirements for evaluating isolated protein amount and integrity prior to molecular assays.
- Documentation & traceability: Emphasis on recording critical pre-analytical variables that can alter protein profiles (e.g., ischemia, handling) and on meeting regulatory or local requirements.
Practical applications
ISO 20184-2:2018 helps reduce pre-analytical variability that can bias molecular diagnostic results by standardizing how frozen tissue and isolated proteins are handled before analysis. Practical uses include:
- Improving reliability and reproducibility of protein-based molecular assays in clinical diagnostics.
- Defining SOPs in molecular pathology laboratories for specimen management, freezing, and protein extraction.
- Informing biobank protocols for collection, storage and distribution of frozen tissue and isolated protein samples.
- Guiding IVD developers and manufacturers in designing assays and instructions that account for pre-examination variables.
- Supporting regulatory compliance and audit readiness by documenting pre-analytical controls and validations.
Who should use this standard
- Medical laboratories and molecular pathology laboratories
- Biobanks and biomedical research institutions
- In vitro diagnostics (IVD) developers and manufacturers
- Laboratory customers, commercial research organizations, and regulatory authorities
Related standards
- ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (referenced normative standard)
- Other parts of the ISO 20184 series (see ISO website for full list)
Keywords: ISO 20184-2:2018, molecular in vitro diagnostic, pre-examination processes, frozen tissue, isolated proteins, protein isolation, cold ischemia, molecular pathology, biobanking, ISO 15189.