GB/T 46943-2025
UpcomingClinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation
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
Application Summary AI generated
This standard specifies the general requirements for validating metagenomic next-generation sequencing (mNGS) assays used in clinical laboratories and in vitro diagnostic systems. It applies to the performance confirmation of pathogen detection workflows, including sample processing, sequencing, and bioinformatics analysis, ensuring accuracy and reliability for infectious disease diagnosis. The standard is intended for use by clinical testing facilities, diagnostic manufacturers, and regulatory bodies in healthcare settings.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.