SN/T 5764-2025 in English
VALIDTechnical Specification for the Preparation of Standard Nucleic Acid Samples of Animal Pathogens
- Issued on:2025-07-25
- Implemented on:2026-02-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$248.00
| Standard No: | SN/T 5764-2025 |
| Document status: | VALID |
| Title in English: | Technical Specification for the Preparation of Standard Nucleic Acid Samples of Animal Pathogens |
| Title in Chinese: | 动物病原核酸标准样品制备技术规范 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2025-07-25 |
| Implemented on: | 2026-02-01 |
| ICS Classification: | 11.220-Veterinary medicine |
| Chinese Classification: | B41-Animal quarantine, veterinary and epidemic prevention |
| Professional Classification: | SN-Import&Export Inspection |
Introduction
Standard Development Background and Technological Evolution
With the rapid development of animal disease detection technology, nucleic acid detection methods have been widely used in the field of animal pathogen detection. However, China has long lacked unified technical specifications for the preparation of standard samples for animal pathogen nucleic acid testing. This has led to technical differences among laboratories in the preparation of standard samples, affecting the accuracy and comparability of test results. The release of SN/T 5764-2025 fills this technical gap and provides comprehensive technical guidance for the standardized preparation of animal pathogen nucleic acid standard samples.
This standard was developed with reference to relevant domestic and international standards, including GB/T15000.7 "Guidelines for Standard Samples Part 7: General Requirements for the Competence of Standard Sample Producers," CNAS-CL04 "Criteria for Accreditation of the Competence of Reference Material/Standard Sample Producers," and CNAS-RLO7 "Rules for Accreditation of Reference Material/Standard Sample Producers," and fully considers my country's biosafety requirements and the actual needs of qualitative animal quarantine testing.
Scope of Application and Core Requirements of the Standard
This document specifies the technical requirements for the competence of animal pathogen nucleic acid standard sample producers, including the preparation process, homogeneity testing, stability testing, value determination methods, packaging, transportation, and storage management. It is applicable to standard sample producers preparing various animal pathogen nucleic acid standard samples, including pathogenic microorganisms such as viruses, bacteria, and parasites.
| Standard sample type | Main features | Applicable pathogens | Storage conditions |
|---|---|---|---|
| Animal pathogen genomic DNA standard sample | Complete genome extraction, maintain natural state | DNA viruses, bacteria, parasites | -20℃ or -80℃ |
| Animal pathogen gene plasmid DNA standard sample | Plasmid vector construction, good stability | Various pathogen-specific genes | -20℃ or -80℃ |
| Animal Pathogen Gene Recombinant DNA Virus Standard Sample | Recombinant viral vector, simulating natural infection | Viral pathogen | -20℃ or -80℃ |
| Animal Pathogen Genomic RNA Standard Sample | Complete RNA extraction, easy to degrade and requires special treatment | RNA virus | -80℃ or freeze-dried |
| Animal Pathogen Gene In Vitro Transcribed RNA Standard Sample | Prepared by in vitro transcription, controlled purity | RNA virus specific sequence | -80℃ or freeze-dried |
| Animal Pathogen Gene Armored RNA Standard Sample | Virus-like particle protection, excellent stability | RNA viruses, especially highly pathogenic viruses | Store at -80°C or freeze-dried |
Key Technical Requirements for Standard Sample Preparation
Producer Capability Requirements
Standard sample producers must meet the general requirements specified in GB/T15000.7, have clear legal status, and a comprehensive quality management system. Production sites must comply with GB 19489, General Requirements for Laboratory Biosafety, and implement appropriate levels of biosafety controls based on the hazard level of the pathogenic microorganisms.
Standardized Preparation Process
The standard specifies detailed preparation processes for six types of nucleic acid standard samples, each with clear process flow charts and technical requirements:
Genomic DNA Standard Sample Preparation Case
Taking the animal pathogen genomic DNA standard sample as an example, the preparation process includes: pathogen selection and identification → genomic DNA extraction → purity and concentration testing → integrity and specificity testing → aliquoting and storage. DNA purity requires an OD260/OD280 ratio between 1.7 and 1.9, concentration is determined by spectrophotometry, and integrity is verified by agarose gel electrophoresis.
Plasmid DNA Standard Sample Preparation Case
Animal Pathogen Gene Plasmid DNA Standard Sample Preparation involves key steps such as target gene selection, plasmid construction, and bacterial strain preservation. The final concentration is controlled at 10³-10⁵ copies/μL, and sample quality is ensured through enzyme linearization and specificity testing.
Quality Control and Validation Requirements
Homogeneity Testing
Homogeneity testing is a key step in ensuring the quality of standard samples. Standard requirements:
- All samples packaged into the smallest packaging unit must be tested for uniformity
- Random sampling is used, and when the total number of units is less than 500, no less than 15 samples are taken
- Analysis of variance (F test) is recommended for statistical testing
- Real-time fluorescence PCR or standard PCR method is usually used
Stability test
Stability test includes transportation stability (short-term stability) and long-term stability:
- Transport stability: measurement temperature 4℃, 25℃ and 37℃, time points 0 week, 1 week, 2 weeks, 4 weeks
- Long-term stability: measurement temperature -20℃ or -80℃, time points 0 month, 1 month, 2 months, 4 months, 6 months, 12 months, etc.
- The stability period of standard samples is generally not less than 1 year
Fixed value requirements
Requirements for the determination process:
- Determination can only be carried out after passing the uniformity and stability tests
- A collaborative determination method is adopted, and the number of laboratories meets the statistical requirements
- When multiple measurement methods are used, the number of independent determination groups is not less than 6
- When the same measurement method is used, the number of independent determination groups is not less than 8
- Traceability requirements: The homology with the known reference sequence is not less than 99%
Packaging, transportation and storage management
| Links | Technical requirements | Precautions |
|---|---|---|
| Packaging | Choose suitable packaging containers to ensure that the material does not affect the characteristic value | The container is well sealed to avoid moisture |
| Transportation | Ensure low temperature transportation conditions | Glass containers must have outer packaging and be marked "Fragile" |
| Storage | Store at -20℃ or -80℃, freeze-dried samples can be stored at 4℃ | Regularly monitor the storage environment to ensure compliance with conditions |
| Management | Establish a testing, identification and traceability system | Periodically conduct external evaluations, including certificate specifications and characteristic value experimental evaluations |
Technical implementation suggestions
Laboratory construction suggestions
It is recommended that standard sample production units establish a complete biosafety laboratory in accordance with standard requirements, equipped with necessary instruments and equipment, including: spectrophotometer, PCR instrument, electrophoresis system, ultra-low temperature refrigerator, lyophilizer, etc. At the same time, strengthen professional personnel training to ensure standardized operation.
Establishment of a quality management system
Establish a quality management system that meets the requirements of GB/T15000.7, formulate SOP documents for the preparation of standard samples, and establish a complete record traceability system. Conduct regular internal audits and external evaluations to ensure continued compliance with standard requirements.
Technological Innovation Directions
With the development of molecular diagnostic technology, it is recommended to focus on the application of new technologies such as digital PCR in the determination of standard sample values to improve the accuracy of determination. At the same time, develop more types of pathogen nucleic acid standard samples to meet different testing needs.
Application Prospects
The implementation of this standard will greatly promote the standardization and regularization of nucleic acid testing for animal diseases, providing reliable technical support for areas such as animal disease prevention and control, import and export quarantine, and food safety supervision. It is expected to play a significant role in the quality control of testing for major animal diseases such as African swine fever and avian influenza.
Significance and Impact of Standard Implementation
The release and implementation of SN/T 5764-2025 has important technical and practical significance:
- It unifies the technical specifications for the preparation of standard samples of animal pathogen nucleic acids, solving the long-standing problem of inconsistent technical standards among laboratories
- It improves the accuracy and comparability of animal disease nucleic acid detection results, providing a reliable technical guarantee for disease diagnosis and prevention
- It promotes the improvement of my country's animal quarantine technology level and enhances its technical voice in international trade
- It provides a technical basis for product quality control of related companies and promotes the development of the industry
This standard will be officially implemented in August 2025. It is recommended that relevant units make technical preparations and personnel training in advance to ensure the smooth implementation of the standard.
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