GB/T 34797-2017 in English
VALIDQuality technical requirements of primers and probes
- Issued on:2017-11-01
- Implemented on:2018-05-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 34797-2017核酸引物探针质量技术要求》由TC387(全国生化检测标准化技术委员会)归口,主管部门为国家标准化管理委员会。
Introduction
1. Standard Overview
GB/T 34797-2017 "Technical Requirements for Quality of Nucleic Acid Primers and Probes" specifies the quality evaluation indicators, technical requirements, test methods, packaging, transportation and storage requirements of DNA primer probes. This standard applies to the quality evaluation and detection of oligonucleotide products such as DNA primer probes.
2. Background of Standard Formulation
With the development of biotechnology, especially the widespread application of gene detection and PCR amplification technology, the quality requirements of nucleic acid primer probes are becoming increasingly important. This standard aims to ensure the reliability and consistency of primers and probes in scientific research and clinical applications.
3. Comparison of standard frameworks
| Standard dimensions | Primer requirements | Probe requirements |
|---|---|---|
| Total OD | ≤10% | 10% |
| Base accuracy | Consistent with custom sequence | Consistent with custom probe sequence |
| Purity level | Desalting grade (≥75%) to HPLC grade (≥95%) | HPLC grade (≥95%) |
4. Interpretation of technical requirements
According to the standards, the quality control indicators of primers and probes include total OD, base accuracy, purity level, base deletion rate, relative molecular mass, etc. For example, HPLC-grade purity primers require a purity of ≥95%, while probes only need to meet HPLC-grade purity (≥95%). In addition, the relative error of relative molecular mass is required to be ≤0.05%.
5. Implementation suggestions
5.1 Quality control process
- Use first-grade water for experiments in accordance with GB/T 6682.
- Use mass spectrometry or high-performance liquid chromatography to determine purity and relative molecular mass.
- Verify the specificity and effect of primers and probes through PCR amplification experiments.
5.2 Precautions
- The synthesis report should include information such as sequence, length, purification method, and modification group.
- Storage conditions must be strictly followed to avoid repeated freezing and thawing that may affect product quality.
- Prevent heavy pressure and sunlight during transportation to ensure safe delivery of the product.

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