News on European quality standards for diagnostics, biobanking and research — and BBMRI.at’s contributions
From pre-analytical guidance for cfDNA in urine and other body fluids to pathogen detection, BBMRI.at contributes to ISO/CEN standards through active work in ISO/TC 212 and CEN/TC 140. This includes pre-analytical sample standards for cfDNA (recently published) and pathogen detection (in development).
NEWLY PUBLISHED: ISO standard for pre-examination of cfDNA from urine and other body fluids recently published
Published at the end of last year, the international standard ISO 18704:2025 specifies requirements and recommendations for the collection, handling, transport, processing, and storage of urine and other body fluids for circulating cell-free DNA (cfDNA) analysis. Developed in ISO/TC 212/WG 4 with contributions from BBMRI.at (through Cornelia Stumptner, Medical University of Graz), it aims to minimize pre-analytical variability to preserve cfDNA quantity and integrity and support reliable assay performance.
Key pre-analytical variables influencing sample quality and thus the analysis result, include patient preparation and timing of collection, specimen type and collection procedure, use of preservatives/stabilizers, time to processing; centrifugation/clarification, transport conditions, storage temperature and duration (including freeze–thaw cycles), measures to prevent cellular lysis and contamination, and documentation/traceability.
BBMRI.at at the CEN/TC 140 Work Group and Plenary meetings
BBMRI.at (represented by Cornelia Stumptner) contributes CEN/TC 140 and attended the recent WG 3 and Plenary at the German Institute for Standardization (DIN). A current focus is “Molecular in vitro diagnostic examinations — Pre-examination processes for human specimens for the detection of infectious pathogens — viruses, bacteria, fungi and parasites,” harmonizing pre-analytical procedures for robust pathogen detection.
Experts also discussed the revision of the pre-analytical series for human specimens, including FFPE tissue (ISO 20166), frozen tissue (ISO 20184), and whole blood (ISO 20186) for isolated DNA/RNA analyses. Originally developed in CEN within the EU project SPIDIA4P and later published as ISO standards, these documents are now undergoing revision after their routine systematic review approximately five years after publication.
The recent CEN/TC 140 meetings gathered international experts working toward harmonized standards for high-quality diagnostics, biobanking, and biomedical research.
From back to front/left to right:
Günther Kalle, Braun Susanne, Arnold Peter, Riegman Peter H.J., Hermes Björn, Gut Ivo, Spitzenberger Folker, Schröder Ulrike, Stumptner Cornelia, Gut Marta, Lindh Linda, Oelmueller Uwe