1 Scope

This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.

This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.

Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186‑3.

This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.