ISO 20186-3:2019 PDF

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

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Title (English):

ISO 20186-3:2019

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 17
Publication date:: September 25, 2019
Edition:: ISO IS 20186 edition 1 version 1
ICS:: 11.100.10

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Description (English):

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

Technical details

Technical committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
SKU: ISO 20186-3:2019

Abstract

Overview

ISO 20186-3:2019 - "Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma" specifies recommendations and requirements for the pre‑examination handling of venous whole blood specimens destined for circulating cell free DNA (ccfDNA) analysis. The standard covers specimen collection in venous whole blood collection tubes, transport, reception, plasma preparation, ccfDNA isolation, quality/quantity assessment, storage and documentation during the pre-analytical phase. It is intended for medical laboratories, in vitro diagnostic (IVD) developers and manufacturers, biobanks, research organizations and regulatory bodies.

Key topics and requirements

Scope and applicability: Applies to ccfDNA prepared from plasma of venous whole blood; does not cover genomic DNA stabilization measures (see ISO 20186-2) or DNA exclusively in exosomes, nor DNA from pathogens in blood.
Pre‑examination workflow: Defines steps from specimen collection through to the start of the analytical test - collection, transport, reception, plasma preparation, ccfDNA isolation and storage.
Specimen collection and tube selection: Emphasizes laboratory selection of appropriate venous whole blood collection tubes and documentation of donor/patient information and storage requirements at the collection site.
Transport and storage: Specifies transport requirements and reception checks to protect the ccfDNA profile from changes (e.g., genomic DNA release from blood cells, degradation or fragmentation).
Plasma preparation and isolation: Requirements for plasma separation and for ccfDNA isolation using either tubes with stabilizers or tubes without stabilizers; addresses impacts of pre‑analytical steps on ccfDNA profiles.
Quality and quantity assessment: Recommends evaluation criteria and documentation for isolated ccfDNA and storage conditions for purified material.
Terminology and requirement language: Uses "shall/should/may/can" to distinguish mandatory requirements, recommendations and permissions.

Applications and users

Medical and clinical laboratories conducting molecular IVD testing (liquid biopsy, oncology, prenatal screening, monitoring).
IVD kit and blood‑collection tube manufacturers validating pre‑analytical workflows.
Biobanks and research institutions standardizing sample handling for reproducible ccfDNA studies.
Regulatory authorities and accreditation bodies evaluating laboratory quality systems. Practical benefits include improved analytical accuracy, reduced pre‑analytical variability, and better reproducibility of ccfDNA‑based assays.

Related standards

ISO 20186-2 - pre‑examination processes for venous whole blood: blood genomic DNA (complements Part 3).
ISO 15189 - Medical laboratories - Requirements for quality and competence (referenced for laboratory quality systems).

Keywords: ISO 20186-3:2019, ccfDNA, circulating cell free DNA, pre-examination, venous whole blood, plasma, molecular in vitro diagnostic, pre-analytical, blood collection tubes, plasma preparation.

Related standards

Mentioned in the description and other ISO standards

Abstract

Overview

Key topics and requirements

Scope and applicability: Applies to ccfDNA prepared from plasma of venous whole blood; does not cover genomic DNA stabilization measures (see ISO 20186-2) or DNA exclusively in exosomes, nor DNA from pathogens in blood.
Pre‑examination workflow: Defines steps from specimen collection through to the start of the analytical test - collection, transport, reception, plasma preparation, ccfDNA isolation and storage.
Specimen collection and tube selection: Emphasizes laboratory selection of appropriate venous whole blood collection tubes and documentation of donor/patient information and storage requirements at the collection site.
Transport and storage: Specifies transport requirements and reception checks to protect the ccfDNA profile from changes (e.g., genomic DNA release from blood cells, degradation or fragmentation).
Plasma preparation and isolation: Requirements for plasma separation and for ccfDNA isolation using either tubes with stabilizers or tubes without stabilizers; addresses impacts of pre‑analytical steps on ccfDNA profiles.
Quality and quantity assessment: Recommends evaluation criteria and documentation for isolated ccfDNA and storage conditions for purified material.
Terminology and requirement language: Uses "shall/should/may/can" to distinguish mandatory requirements, recommendations and permissions.

Applications and users

Medical and clinical laboratories conducting molecular IVD testing (liquid biopsy, oncology, prenatal screening, monitoring).
IVD kit and blood‑collection tube manufacturers validating pre‑analytical workflows.
Biobanks and research institutions standardizing sample handling for reproducible ccfDNA studies.
Regulatory authorities and accreditation bodies evaluating laboratory quality systems. Practical benefits include improved analytical accuracy, reduced pre‑analytical variability, and better reproducibility of ccfDNA‑based assays.

Related standards

ISO 20186-2 - pre‑examination processes for venous whole blood: blood genomic DNA (complements Part 3).
ISO 15189 - Medical laboratories - Requirements for quality and competence (referenced for laboratory quality systems).

Keywords: ISO 20186-3:2019, ccfDNA, circulating cell free DNA, pre-examination, venous whole blood, plasma, molecular in vitro diagnostic, pre-analytical, blood collection tubes, plasma preparation.

ISO 20186-3:2019 PDF

Technical details

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole bl…

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