T/CITS 275-2025 Active Group standards

T/CITS 275-2025 The clinical requirements for automating and standardizing next-generation sequencing technology

Publish Date: 2025-02-17 Implement Date: 2025-02-17 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/CITS 275-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Laboratory medicine

Publish Date: 2025-02-17

Implement Date: 2025-02-17

Scope

Scope: This document specifies the general requirements for the automation and standardization of clinical next-generation sequencing, as well as technical requirements for standardized sampling, automated nucleic acid extraction and purification, library construction, gene sequencing systems, bioinformatics analysis, quality control, report interpretation and genetic counseling, medical informatics systems, training and education, and data management. This document is applicable to hospitals and third-party medical institutions' laboratories engaged in clinical next-generation sequencing work in the fields of oncology, genetics, and pathogenic microorganisms. Main technical contents: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions 4 Abbreviations 5 General requirements 5.1 Standardized processes 5.2 Equipment automation 5.3 Equipment standardization 5.4 Data management and analysis 5.5 Personnel qualifications and training 5.6 Information security 6 Technical requirements 6.1 Standardized sampling 6.2 Automated nucleic acid extraction and purification and library construction 6.3 Gene sequencing systems 6.4 Bioinformatics analysis 6.5 Quality control 6.6 Report interpretation and genetic counseling 6.7 Medical informatics systems 6.8 Training and education 6.9 Data management References