Overview
ISO 23118:2021 specifies requirements and recommendations for the pre-examination (pre-analytical) handling, documentation and processing of urine, venous blood serum and plasma intended for metabolomics analysis. The standard addresses steps from patient preparation and primary specimen collection through transport, reception, processing, storage and thawing, with the goal of preserving the original metabolome for reliable mass spectrometry (MS) and NMR-based metabolomics. It is intended for biomedical laboratories, in vitro diagnostics (IVD) developers, researchers, biobanks and regulatory authorities.
Key topics and technical requirements
- Pre-examination scope: patient preparation (e.g., fasting), specimen collection, identification and documentation.
- Specimen types: urine, venous blood serum and plasma (primary samples).
- Critical pre-analytical steps:
- Primary collection and use of appropriate collection containers and additives.
- Transport requirements and temperature control (room temperature defined as 18–25 °C).
- Specimen reception and logging in the laboratory.
- Processing workflows: aliquoting, centrifugation, removal of cells to limit enzymatic activity.
- Storage requirements: short-term and long-term storage, thawing procedures and limits on freeze–thaw cycles.
- Metabolome stability: attention to enzymatic activities and chemical reactions (e.g., redox, oxidation) that can alter metabolite profiles; adoption of stabilization or rapid processing to mitigate changes.
- Risk assessment and quality: perform risk analyses (e.g., per ISO 14971 principles) and follow laboratory quality/safety standards (ISO 15189, ISO 15190).
- Documentation: record any additions, modifications, container types, sample quantities and chain-of-custody to enable comparability and reproducibility.
Applications and who uses it
ISO 23118:2021 is practical for:
- Clinical and research laboratories running untargeted or targeted metabolomics (MS, NMR).
- IVD developers and manufacturers validating assays and specifying pre-analytical constraints.
- Biobanks implementing standardized collection, storage and retrieval procedures for metabolomics studies.
- Multicentre research consortia seeking harmonized pre-analytical workflows to ensure data comparability.
- Regulatory bodies and quality managers assessing conformity and pre-analytical risk mitigation.
Benefits include improved sample integrity, reduced pre-analytical variability, and enhanced comparability of metabolomics data across sites and platforms.
Related standards
- ISO 15189 - Medical laboratories - Requirements for quality and competence
- ISO 15190 - Medical laboratories - Requirements for safety
- ISO/IEC 17020 - Conformity assessment (applicable where relevant)
- ISO 14971 - Risk management for medical devices (referenced for risk assessment)
Keywords: ISO 23118:2021, metabolomics pre-examination, urine metabolomics, serum plasma handling, sample collection, pre-analytical workflow, mass spectrometry, NMR, biobank standards.