DZ/T 0101.12-1994
Active
GB/T 46943-2025
Pending
National standards
GB/T 46943-2025 Clinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation
GB/T 46943-2025 Clinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation
Price:
$ 44.00
Basic Information
Standard Code:
GB/T 46943-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2025-12-31
Implement Date:
2027-01-01
Pages:
20 pages
Scope
This document specifies the requirements for performance verification before clinical laboratories conduct metagenomic next-generation sequencing (mNGS) of pathogens.
This document applies to the performance verification of mNGS conducted by clinical laboratories using high-throughput sequencing technology.
This document does not apply to the performance verification of single-molecule pathogen sequencing based on technologies such as biological nanopores and solid-state nanopores, nor to the performance verification of pathogen sequencing established using targeted probe hybridization capture or multiple primer amplification techniques.
Development Information
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