GB/T 43628-2023
Metagenomic sequencing and identification method of airborne pathogenic microorganisms (English Version)
- Standard No.
- GB/T 43628-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 43628-2023
- Scope
- This document specifies the test conditions, test steps, quality control and identification of metagenomic sequencing of pathogenic microorganisms in the air. This document is applicable to metagenomic sequencing, identification and monitoring of pathogenic microorganisms such as bacteria, fungi and viruses in the air.
- Introduction
1. Background and significance of standard formulation
With the frequent occurrence of global public health events, the detection and identification of pathogenic microorganisms in the air has become an important part of infectious disease prevention and control and environmental monitoring. Metagenomic sequencing technology has shown unique advantages in pathogenic microorganism detection due to its high throughput, rapidity and accuracy.
2. Comparison of standard frameworks
Standard Dimensions GB/T 43628—2023 ISO Reference Standard Difference Analysis Scope of Application Applicable to metagenomic sequencing, identification and monitoring of pathogenic microorganisms such as bacteria, fungi and viruses in the air. ISO standards are mainly aimed at bioaerosol detection in laboratory environments. GB/T 43628 expands the scope of application to cover public places and medical and health environments. Sampling method Specifies the flow rate requirements of the aerosol sampler (≥50 L/min or ≥300 L/min) and the storage conditions after sample collection. The ISO standard does not specify the sampler performance parameters in detail. GB/T 43628 is more specific in the sampling technology details to ensure the repeatability of the data. Data analysis Requires that the sequencing data volume be ≥1 Gb and that the data quality be strictly controlled (Q20 accounts for ≥90%). The ISO standard does not specify the data volume and quality requirements. GB/T 43628 is more operational in terms of data processing standardization. 3. Interpretation of key technologies
Aerosol sampler:Flow rate requirement is ≥50 L/min (filtration type) or ≥300 L/min (centrifugal type), ensuring that the sampling efficiency is not less than 70%. This directly affects the representativeness of the sample.
Nucleic acid extraction and library preparation:Use a trace nucleic acid extraction kit, and the total amount of extraction is not less than 50 ng. Library preparation must meet the requirements of the sequencing platform and perform quality testing (such as fragment length and concentration).
4. Implementation Suggestions
Case Study: Comparison and Analysis of Sequencing Data of Yersinia pestis and SARS Virus
Use Kraken software to build a public database and a custom database, and build a standard library and a custom library for the new coronavirus respectively. Through parameter settings (such as --confidence threshold), high-quality data analysis can be completed.
GB/T 43628-2023 Referenced Document
- GB 19489 Laboratories.General requirements for biosafety
- GB 41918 Biological safety cabinets
- GB/T 18204.3 Examination methods for public places.Part 3:Airborne microorganism
- GB/T 30989 Technical regulation of high-throughput gene sequencing
- GB/T 39990 Particulate─Bioaerosol sampler─Technical specification
- GB/T 40974 Quality evaluation methods of the nucleic acid
- GB/T 6682 Water for analytical laboratory use.Specification and test methods
- WS 589 Pathogenic microbiology laboratory biosafety sign
GB/T 43628-2023 history
- 2023 GB/T 43628-2023 Metagenomic sequencing and identification method of airborne pathogenic microorganisms