T/YEMS 001-2023 Active Group standards

T/YEMS 001-2023 Genomic Health Assessment Technical Specification

T/YEMS 001-2023 Genomic Health Assessment Technical Specification

Publish Date: 2023-01-11 Implement Date: 2023-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/YEMS 001-2023
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2023-01-11
Implement Date: 2023-03-01

Scope

Scope: Genome stability is a fundamental genetic factor for health promotion and improving public health quality. Genome damage is a biological indicator of genome health being compromised. This document specifies the cellular and molecular biological principles and techniques, as well as operational guidelines for minimally invasive detection of genome damage in humans. This document is applicable to genetic health consultations based on genome health evaluation, providing scientific evidence for "Level 0 Prevention" characterized by health management, healthy lifestyles, and public health strategies. Main technical content: 1. Minimally invasive peripheral venous blood sampling: Sampling requires ethical review and informed consent. Subjects should provide reports of HBV, HCV, HIV, and syphilis tests within the past three months. Those positive for any of these pathogens are temporarily excluded from this health evaluation analysis. Qualified personnel collect 3ml of blood using heparin sodium anticoagulation and complete lymphocyte isolation and culture, as well as nuclear genome DNA extraction within 48 hours. 2. Lymphocyte culture and preparation 2.1 Quality requirements for culture medium: Standard RPMI1640 medium containing 10% fetal bovine serum, 2mM L-Glu, 30μg/ml plant hemoglobin agglutinin, 1mM sodium pyruvate, and 100 IU/ml dual antibody is used. The medium is sterilely packaged and stored at 4°C in the dark for use within one week. 2.2 Quality requirements for lymphocyte isolation and counting: Peripheral venous blood samples are diluted with HBSS at room temperature (15-28°C) and lymphocytes are isolated according to the lymphocyte isolation solution instructions. The lymphocytes are washed three times with HBSS, centrifuged at 1000rpm for 10 minutes, and counted. 2.3 Cell culture, cytokinesis blockage, and preparation: Lymphocytes are inoculated into 10ml round-bottom sterile tubes containing 800μL RPMI1640 medium to achieve a final c

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