Standard Document
ISO

ISO20186-3

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma

This document provides essential guidelines for optimizing the handling, storage, processing, and documentation of venous whole blood specimens for genomic DNA analysis. Designed for molecular diagnostic laboratories, IVD developers, biobanks, and research institutions, it helps ensure high-quality, reliable DNA results. While focused on venous whole blood collection tubes, it excludes circulating cell-free DNA (covered in ISO 20186-3), dried blood technologies, and pathogen DNA.

September 01, 2019

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ISO20186-3E
17