GB/T 46943-2025
GB/T 46943-2025 Clinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation
Abstract
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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Pending |
| Standard Code | GB/T 46943-2025 |
| CCS | Medical devices |
| Implement Date | 2027-01-01 |