GB/T 46943-2025Clinical laboratory testing and in vitro diagnostic test systems - General requirements for the validation of metagenomic next-generation sequencing (English PDF)
临床实验室检测和体外诊断系统 病原宏基因组高通量测序性能确认通用要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 31, 2025
Implementation date
January 1, 2027
Scope
GB/T 46943-2025 is the English-translated version of 临床实验室检测和体外诊断系统 病原宏基因组高通量测序性能确认通用要求.
GB/T 46943-2025 is the Chinese standard "Clinical laboratory testing and in vitro diagnostic test systems - General requirements for the validation of metagenomic next-generation sequencing".
Its scope clause reads: This document specifies the procedures for clinical testing laboratories to conduct metagenomic next-generation sequencing (MRGS). This document applies to clinical testing laboratories using high-throughput sequencing technology to perform mNGS performance validation.
This document does not apply to the performance validation of single-molecule pathogen sequencing that uses biological nanopores, solid-state nanopores, or similar technologies as its primary technical principles.
This method is not applicable to the performance validation of pathogen sequencing established using targeted probe hybridization capture or multiple primer amplification techniques. Its clauses include terms and definitions.
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Document preview — GB/T 46943-2025
National Standard of the People's Republic of China
- ICS
- 11.100.10
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4 Requirements
- 4.1 Preparation of Performance Validation Specimens
- 4.2 Performance Validation of Key Testing Steps
- 4.3 Performance Validation of the Complete Process
- 4.4 Performance Validation Report
- References
1 Scope
This document specifies the procedures for clinical testing laboratories to conduct metagenomic next-generation sequencing (MRGS).
This document applies to clinical testing laboratories using high-throughput sequencing technology to perform mNGS performance validation.
This document does not apply to the performance validation of single-molecule pathogen sequencing that uses biological nanopores, solid-state nanopores, or similar technologies as its primary technical principles.
This method is not applicable to the performance validation of pathogen sequencing established using targeted probe hybridization capture or multiple primer amplification techniques.
2 Normative references
This document has no normative references.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Characterized by the ability to sequence hundreds of thousands to millions of nucleic acid molecules simultaneously and generally with short read lengths, it is suitable for DNA sequencing.
technology.
[Source. GB/T 30989-2014, 3.19, with modifications]
3.2
A detection technique for unbiased sequencing of the DNA and/or RNA of all pathogenic microorganisms in a specimen.
[Source. ISO /T S24420.2023, 3.23, with modifications]
3.3 Performance validation
The determination that a specific intended use or application requirement has been met by providing objective evidence.
[Source. GB/T 19000-2016, 3.8.13, with modifications]
3.4
The length of the longest gene fragment that can be sequenced is usually expressed in terms of the number of bases.
[Source. GB/T 30989-2014, 3.24]
3.5 Library
A reconstructed molecular group obtained through biological, synthetic, or cloning techniques.
Examples. genomic libraries, complementary DNA libraries, phage display peptide libraries, etc.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 14 pages — is available in the English PDF.
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