GB/T 43286-2023 in English
VALIDDisposable sampling tube (inactivated type)
- Issued on:2023-11-27
- Implemented on:2023-11-27
- File Format:PDF
- Delivery:Via email within 5 business days
Price(USD):
$490.00
$476.00
$476.00
《GB/T 43286-2023一次性采样管(灭活型)》由TC559(全国生物样本标准化技术委员会)归口,主管部门为国家标准委。
Introduction
Analysis of core requirements of the standard
| Technical indicators | Requirements | Test methods |
|---|---|---|
| Inactivation performance | Complete inactivation of viral activity (enveloped/non-enveloped viruses) | Appendix C Blind third-generation + TCID50 detection |
| Nucleic acid stability | Ct value change rate within 48h ≤5% | Appendix D Fluorescence quantitative PCR |
| Sealing performance | Mass difference ≤5mg or no leakage under 90kPa negative pressure | Weight method/vacuum negative pressure method |
Key technical parameters
Sampling liquid composition requirements
Must contain: protein denaturant (guanidine isothiocyanate, etc.), surfactant (SDS, etc.); prohibited ingredients: heparin PCR inhibitors. Solvents must use ≥18MΩ·cm ultrapure water.
Sampling tube specifications comparison
| Dimensions (mm) | Filling volume (mL) | Swab capacity |
|---|---|---|
| 50×10 | 1.0±0.2 | 1 piece |
| 100×16 | 6.0±0.5 | 10 pieces |
Implementation points
- Biological safety cabinet Selection: HIV testing requires BSL-3, influenza virus requires BSL-2
- Quality control: Factory inspection requires 100% appearance inspection + batch sealing/nucleic acid stability sampling
- Transportation and storage: Avoid freezing below -20℃ which may cause the tube to rupture
Sample only — not a preview of GB/T 43286-2023

Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.