GB/T 43279.2-2023 Active National standards

GB/T 43279.2-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA

Publish Date: 2023-11-27 Implement Date: 2024-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 43279.2-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2023-11-27

Implement Date: 2024-06-01

Pages: 19 pages

Scope

This document provides operational guidelines for the pre-test phase of venous whole blood samples used for genomic DNA testing, including sample handling, storage, processing, and recording. This document covers samples collected in venous whole blood collection tubes.
This document is applicable to molecular in vitro diagnostic tests conducted in medical laboratories, as well as laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations engaged in biomedical research, and regulatory authorities.
This document does not address dedicated methods for stabilizing circulating free DNA in blood.
Note: For information on circulating free DNA in blood, please refer to GB/T 43279.3—2023.
This document does not address the collection, stabilization, transportation, and storage of capillary blood, nor dedicated methods for collecting and storing blood using paper-based technology or other techniques that can produce dried blood.
This document does not address the separation of specific blood cells and subsequent isolation of genomic DNA.
This document does not address pathogen DNA present in blood.