Overview
EN ISO 23118:2021 (ISO 23118:2021) defines specifications for the pre-examination processes used in metabolomics analyses of urine, venous blood serum and plasma. It establishes requirements and recommendations for sample collection, handling, transport, storage, processing and documentation to preserve the native metabolome and ensure reliable, comparable results across laboratories, biobanks and multicentre studies. The standard was prepared by ISO/TC 212 in collaboration with CEN/TC 140 and supersedes CEN/TS 16945:2016.
Key topics and technical requirements
- Scope and applicability: Applies to metabolomics examinations and is intended for biomedical laboratories, customers, IVD developers and manufacturers, research institutions, biobanks and regulatory authorities.
- Pre-analytical risk factors: Emphasizes prevention of artefacts caused by enzymatic activity (cell-derived) and chemical reactions (e.g., oxidation) that can alter the metabolome during collection, transport and storage.
- Sample collection and primary handling: Requirements for urine and venous blood (serum/plasma) collection, appropriate choice of collection tubes and plasticware to avoid additives and contaminants that may bias metabolomic profiles.
- Transport and specimen reception: Defined transport conditions and laboratory reception processes to control time, temperature and handling that affect metabolite stability.
- Processing and storage: Procedures for sample processing (centrifugation, aliquoting), short- and long-term storage requirements including thawing and handling of frozen samples to minimise metabolome changes.
- Documentation and traceability: Mandatory documentation of pre-analytical steps to support data integrity and comparability in diagnostic and research settings.
- Instability considerations: Annex on metabolome instability and factors influencing analytical outcomes; draws on MS and NMR analytical characteristics (MS sensitivity to picomolar levels; NMR detection generally above ~1 µM).
- Normative references: Links to ISO 15189 (quality and competence for medical laboratories) and ISO 15190 (laboratory safety).
Applications and users
- Clinical and research metabolomics laboratories implementing standardized pre-analytical workflows.
- Biobanks that collect and store urine and blood specimens for metabolomic studies.
- IVD developers and manufacturers designing assays and consumables (tubes, stabilizers) compatible with metabolomics requirements.
- Regulatory authorities and multicentre study coordinators who require harmonized sample handling to ensure reproducible biomarker discovery and validation.
Related standards
- ISO 15189 - Medical laboratories - Requirements for quality and competence.
- ISO 15190 - Medical laboratories - Requirements for safety.
- Supersedes CEN/TS 16945:2016.
EN ISO 23118:2021 is essential for teams focused on reliable metabolomics data generation and comparability across sites by controlling pre-analytical variability in urine, serum and plasma samples.