Overview
EN ISO 18704:2026 sets international requirements and recommendations for the pre-examination processes involving cell-free DNA (cfDNA) from urine and other human body fluids excluding blood. This European standard focuses on ensuring the integrity and quality of cfDNA specimens through standardized procedures for collection, handling, storage, transport, processing, and documentation. The document is designed for use in molecular in vitro diagnostic examinations, targeting the growing demand for reliable cfDNA analysis in varied clinical and research environments.
The scope emphasizes various body fluids such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva. By codifying essential steps before cfDNA examination, EN ISO 18704:2026 supports laboratories, diagnostic developers, biobanks, biomedical researchers, and regulatory authorities in aligning with best practices for specimen management.
Key Topics
EN ISO 18704:2026 highlights several critical topics in the pre-analytical phase for cfDNA:
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Specimen Collection:
Outlines requirements for body fluid collection, including patient identification, health and treatment status documentation, and selection of appropriate collection devices or stabilizers to minimize cfDNA degradation.
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Specimen Handling and Transport:
Details procedures for the safe and effective transport of body fluids, addressing the need for temperature control, timely delivery, and use of stabilization compounds where appropriate.
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Storage Guidelines:
Provides instructions for the short- and long-term storage of specimens and isolated cfDNA to maintain analyte stability and prevent degradation.
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Processing Methods:
Describes necessary steps such as centrifugation to purify specimens and standardize cfDNA isolation techniques to ensure consistency and reliability for downstream molecular analysis.
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Documentation and Traceability:
Stresses comprehensive record-keeping throughout all pre-examination processes to enable traceability, quality management, and compliance with regulatory frameworks.
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Risk Management:
Encourages proactive assessment and mitigation of risks that may compromise cfDNA integrity, including microbial contamination, cross-contamination, and inappropriate handling.
Applications
EN ISO 18704:2026 has broad practical significance across the healthcare and life science sectors, supporting:
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Medical Laboratories:
Enhances reliability and reproducibility of molecular diagnostics performed on cfDNA from urine and other body fluids in patient care.
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Diagnostic Development:
Assists in vitro diagnostic developers and manufacturers in designing workflows and kits optimized for non-blood fluid cfDNA analysis.
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Biobanking:
Standardizes storage and handling protocols in biobanks to ensure high-quality cfDNA specimens for future research and diagnostics.
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Biomedical Research:
Facilitates consistent pre-analytical procedures, enabling robust comparative studies and the development of new cfDNA-based applications, such as cancer liquid biopsies or genetic monitoring.
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Regulatory Compliance:
Guides institutions and authorities in assessing laboratory practices, aiding compliance with European and international norms for specimen management.
Related Standards
For comprehensive practice and quality assurance, organizations should consider the following related standards:
- ISO 15189: Medical laboratories - Requirements for quality and competence
- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 20186-3: Molecular in vitro diagnostic examinations - Pre-examination processes for circulating cell-free DNA from blood
- ISO 20658: Medical laboratories - Requirements for collection, transport, receipt, and handling of samples
- ISO 20387: Biobanking - General requirements for biobanking
- ISO 14971: Medical devices - Application of risk management to medical devices
By implementing EN ISO 18704:2026 and harmonizing with these related standards, organizations can drive improvements in the accuracy, consistency, and safety of cfDNA-based molecular diagnostics from urine and other body fluids.