ISO 20186-2:2019 PDF

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

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Title (English):

ISO 20186-2:2019

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 20
Publication date:: February 19, 2019
Edition:: ISO IS 20186 edition 1 version 1
ICS:: 11.100.10

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Description (English):

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination 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 cell free circulating DNA, which are not described in this document. NOTE Circulating cell free DNA in blood is covered in ISO 20186-3. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. 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 20186-2:2019

Abstract

Overview - ISO 20186-2:2019 (Molecular IVD pre‑examination for venous whole blood - Isolated genomic DNA)

ISO 20186-2:2019 provides guidance for the pre‑examination phase of molecular in vitro diagnostic (IVD) testing where genomic DNA is the analyte. The standard covers handling, storage, processing and documentation of venous whole blood specimens collected in blood collection tubes, up to the point where the analytical molecular examination begins. It focuses on preserving genomic DNA integrity (including high molecular weight DNA) and reducing degradation/fragmentation during collection, transport, reception, processing and storage.

Key technical topics and requirements

Specimen collection: selection of appropriate venous whole blood collection tubes and information required about the donor/patient and specimen at collection.
Stabilization: measures to minimize genomic DNA degradation and fragmentation (note: circulating cell‑free DNA stabilization is excluded and covered in ISO 20186‑3).
Transport and storage: requirements for safe transport and interim storage before laboratory processing. The document also defines terms such as room temperature (18 °C to 25 °C).
Laboratory reception and processing: procedures for specimen reception, accessioning, and documentation to maintain chain of custody and specimen traceability.
Isolation of genomic DNA: guidance on isolation workflows, whether using commercial kits or in‑house protocols; includes recommendations on following examination provider’s instructions when available.
Quality and quantity assessment: requirements for assessing isolated genomic DNA quality (e.g., suitability for assays requiring HMW DNA) and documenting results.
Storage of isolated genomic DNA: recommendations for storage practices depending on method of isolation and intended downstream use.
Terminology and scope limitations: definitions for genomic DNA, HMW DNA (>50 kb on pulsed‑field gel for this document), analyte, pre‑examination processes, and exclusions (capillary blood, dried blood methods, pathogen DNA, and isolated blood cell DNA are not covered).

Practical applications

Standardizes preanalytical workflows to improve reliability and reproducibility of molecular IVD results.
Helps laboratories minimize sample degradation that would compromise diagnostics, sequencing, genotyping or other genomic assays-especially those needing high molecular weight DNA.
Supports biobanks and research institutions in specimen handling and documentation for long‑term storage and data quality.
Guides IVD developers and manufacturers when qualifying primary sample collection devices and reagents.

Who should use this standard

Clinical and medical laboratories performing molecular IVD testing
Laboratory customers and clinicians ordering genomic assays
IVD developers and manufacturers, biobanks, research organizations and regulatory authorities

Related standards

ISO 20186 series (see ISO 20186‑3 for circulating cell‑free DNA)
ISO 15189:2012 (medical laboratory quality and competence)

Keywords: ISO 20186-2, genomic DNA, venous whole blood, pre‑examination processes, molecular IVD, preanalytical, sample handling, DNA isolation, high molecular weight DNA, biobanking.

Related standards

Standards mentioned in the description

Abstract

Overview - ISO 20186-2:2019 (Molecular IVD pre‑examination for venous whole blood - Isolated genomic DNA)

Key technical topics and requirements

Specimen collection: selection of appropriate venous whole blood collection tubes and information required about the donor/patient and specimen at collection.
Stabilization: measures to minimize genomic DNA degradation and fragmentation (note: circulating cell‑free DNA stabilization is excluded and covered in ISO 20186‑3).
Transport and storage: requirements for safe transport and interim storage before laboratory processing. The document also defines terms such as room temperature (18 °C to 25 °C).
Laboratory reception and processing: procedures for specimen reception, accessioning, and documentation to maintain chain of custody and specimen traceability.
Isolation of genomic DNA: guidance on isolation workflows, whether using commercial kits or in‑house protocols; includes recommendations on following examination provider’s instructions when available.
Quality and quantity assessment: requirements for assessing isolated genomic DNA quality (e.g., suitability for assays requiring HMW DNA) and documenting results.
Storage of isolated genomic DNA: recommendations for storage practices depending on method of isolation and intended downstream use.
Terminology and scope limitations: definitions for genomic DNA, HMW DNA (>50 kb on pulsed‑field gel for this document), analyte, pre‑examination processes, and exclusions (capillary blood, dried blood methods, pathogen DNA, and isolated blood cell DNA are not covered).

Practical applications

Standardizes preanalytical workflows to improve reliability and reproducibility of molecular IVD results.
Helps laboratories minimize sample degradation that would compromise diagnostics, sequencing, genotyping or other genomic assays-especially those needing high molecular weight DNA.
Supports biobanks and research institutions in specimen handling and documentation for long‑term storage and data quality.
Guides IVD developers and manufacturers when qualifying primary sample collection devices and reagents.

Who should use this standard

Clinical and medical laboratories performing molecular IVD testing
Laboratory customers and clinicians ordering genomic assays
IVD developers and manufacturers, biobanks, research organizations and regulatory authorities

Related standards

ISO 20186 series (see ISO 20186‑3 for circulating cell‑free DNA)
ISO 15189:2012 (medical laboratory quality and competence)

Keywords: ISO 20186-2, genomic DNA, venous whole blood, pre‑examination processes, molecular IVD, preanalytical, sample handling, DNA isolation, high molecular weight DNA, biobanking.

ISO 20186-2:2019 PDF

Technical details

Abstract

Overview - ISO 20186-2:2019 (Molecular IVD pre‑examination for venous whole blood - Isolated genomic DNA)

Key technical topics and requirements

Practical applications

Who should use this standard

Related standards

Related standards

Abstract

Overview - ISO 20186-2:2019 (Molecular IVD pre‑examination for venous whole blood - Isolated genomic DNA)

Key technical topics and requirements

Practical applications

Who should use this standard

Related standards

Related standards

Medical laboratories — Requirements for quality and competence

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

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