GB/T 41895-2022 in English
VALIDDetermination for DNA viruses of cell—MNP marker method
- Issued on:2022-10-12
- Implemented on:2022-10-12
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
《GB/T 41895-2022细胞中DNA病毒测定 MNP标记法》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
Analysis of the core technological innovation of the method
This method adopts multi-nucleotide polymorphism (MNP) labeling technology and relies on the second-generation high-throughput sequencing platform to achieve the following key breakthroughs:
Comparison of technological innovation (technical module/conventional PCR, detection sensitivity)| Technical dimension | MNP labeling method | Traditional qPCR |
|---|---|---|
| Maximum detection variety | 9 viruses | Single target |
| Sensitivity (LOD) | 10 copies/reaction | 10²~10³ |
| Comparison of refund points | Identification of multiple syndromes | Determination of single pathogen |
Experimental equipment and sample specifications
Key technical equipment includes:
- PCR amplification instrument: professional model with 30-second rapid temperature rise and fall
- High-throughput sequencer: Minimum BioMEMS microfluidic chip system
A260/A280 ∈ [1.7,1.9] A260/A230 > 2.0
Analysis of key quality control points
Sequencing quality control threshold
| Quality control indicators | Conversion conditions | Handling measures |
|---|---|---|
| <50Mb data | Construction failure | 7.3 stage reanalysis |
| 50-100Mb | Abnormal samples | DNA repeated extraction and amplification |
| Internal control DNA detection sites | >=17 | Otherwise clearly out of control |
Clinical diagnosis application scenarios
Applicable fields include virus clearance evaluation after vaccination, blood product cell bank testing, etc.
EB virus determination rules:
Clear detection when overlap ≥3 marker sites (47 specific probes) and signal-to-noise ratio ≥10
False positive prevention mechanism:
Non-specific amplification signals are filtered out by internal control flux negative control to reach 2×10⁻⁴Pharmacological level elimination

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