GB/T 43279.3-2023 Active National standards

GB/T 43279.3-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 3:Isolated circulating cell free DNA from plasma

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 43279.3-2023

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: 18 pages

Scope

This document provides guidelines for the pre-test phase of venous whole blood samples used for circulating cell-free DNA (ccfDNA) 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 to molecular in vitro diagnostic tests conducted by 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 genomic DNA in blood. For information on genomic DNA in blood, see ISO 20186-2.
This document does not address dedicated methods for preserving DNA in circulating exosomes.
Note: The ccfDNA obtained from blood through the procedures referenced in this document may include DNA from exosomes [10-11].
This document does not address pathogen DNA present in blood.