T/WJWCHCA 001-2024 Targeted second-generation sequencing detection technology specification for respiratory tract pathogen detection based on multiple PCR

Scope

Scope: This standard specifies the methods and procedures for pathogen detection in respiratory clinical specimens (including pre-analysis, analysis, and post-analysis) using targeted second-generation sequencing technology based on multiplex PCR, as well as performance verification or confirmation and quality control. This standard applies to medical institutions that use targeted second-generation sequencing technology based on multiplex PCR for pathogen detection in respiratory clinical specimens. Main technical content: This group standard focuses on the application of tNGS in respiratory infections and provides comprehensive norms and introductions, covering: - In the technical application section, it clarifies the application scenarios, detection scope (including upper and lower respiratory tracts) and specimen selection, indicating that the rational application of products is conducive to accurate clinical diagnosis. - The experimental principle chapter elaborates on the key experimental techniques of the tNGS experimental process. - The laboratory zoning, instrumentation and reagents chapter standardizes laboratory zoning, related equipment, reagents, and personnel qualifications. - The performance verification or confirmation chapter provides recommendations on scheme selection, performance verification and confirmation. - Pre-analysis norms regulate the specimen collection, storage and transportation of respiratory tNGS. - Analysis-in-process norms regulate key inspection processes such as scheme selection, specimen processing, nucleic acid extraction, library construction, second-generation sequencing, and bioinformatics analysis. - Post-analysis norms regulate pathogen reporting processes, result reporting issuance, handling of false-negative and false-positive results, and clinical specimen storage, retention, and disposal. - The quality control chapter standardizes quality control at all stages of pre-, in-, and post-analysis.

Development Information

Related Standards