Overview
EN ISO 20184-2:2018 - “Molecular in vitro diagnostic examinations - Specifications for pre‑examination processes for frozen tissue - Part 2: Isolated proteins” provides guidance for the pre‑analytical handling of frozen tissue specimens intended for the examination of isolated proteins. The document standardizes procedures around handling, documentation, storage and processing during the pre‑examination phase to minimize artefactual changes to protein profiles that can arise during collection, transport and storage. It complements laboratory quality systems (referenced to ISO 15189) and is aimed at ensuring reliable molecular in vitro diagnostic (IVD) results.
Key Topics
The standard addresses practical, pre‑analytical requirements including:
- Specimen collection: required information about the specimen donor/patient and specimen metadata; specimen processing considerations.
- Transport of fresh tissue: preparatory and in‑transit requirements to reduce degradation and preserve protein integrity.
- Reception and documentation: recording specimen arrival and conditions at the laboratory.
- Pathology evaluation and sample selection: procedures for assessing tissue pathology and selecting suitable sample(s) for protein isolation.
- Freezing and storage: recommended approaches for freezing samples and maintaining frozen storage to limit cold ischemia effects.
- Isolation of total protein: guidance on extracting proteins from frozen tissue, including use of commercial kits or in‑house protocols.
- Quantity and quality assessment: requirements for evaluating the yield and integrity of isolated proteins prior to molecular assays.
- Storage of isolated proteins: conditions and recordkeeping for storing extracted protein material.
- Pre‑analytical risk factors: managing changes caused by warm and cold ischemia, degradation, and treatment effects.
- Annex on experimental evidence: e.g., how cold ischemia can alter protein quantities (informative).
Note: chemically stabilized tissues before freezing and protein assessment by immunohistochemistry are outside the scope.
Applications
- Standardizes pre‑analytical workflows for laboratories performing molecular in vitro diagnostic protein assays on frozen tissue.
- Helps reduce variability and improve assay reproducibility by limiting pre‑examination artifacts (protein degradation, induction or loss).
- Supports development and validation of IVD kits and laboratory protocols for protein isolation and downstream molecular testing.
- Useful for biobanks and research organizations to implement consistent frozen tissue handling and documentation practices.
- Assists regulatory bodies and quality managers in assessing compliance with pre‑analytical requirements.
Who should use this standard
- Medical laboratories and molecular pathology laboratories
- In vitro diagnostics developers and manufacturers
- Biobanks and biomedical research institutions
- Laboratory customers and clinical investigators
- Regulatory authorities and quality assurance teams
Related standards
- ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (normative reference).