As a key consumable for virus sample collection and preservation, the quality control of disposable sampling tubes directly affects the accuracy of nucleic acid testing. At present, China mainly regulates based on the group standard T/SAMD001-2021 and the national standard GB/T43286-2023, with core control indicators covering four dimensions: materials, sealing, preservation liquid performance, and microbiological indicators.
Material requirements: The main body of the sampling tube is mostly made of medical grade polypropylene (PP) or glass, which should have corrosion resistance and radiation resistance characteristics to ensure structural integrity in the environment. The swab rod is usually made of ABS material, while the swab head is made of flocking or fiber material to improve sample collection efficiency. For example, GB/T43286-2023 specifies that the material of the pipe body must comply with YY/T0242 standard to ensure chemical stability.
Sealing test: Sealing is the core indicator to prevent sample leakage. The standard stipulates the use of vacuum negative pressure method, and the sampling tube should be placed under a pressure of -90kPa for 3 minutes, without water or bubbles entering the tube. In addition, the weight analysis method requires a mass difference of no more than 5mg after simulating 12 hours of transportation, and double validation ensures the reliability of the seal.
Performance of preservation solution: The preservation solution needs to maintain the stability of viral nucleic acid and inhibit degradation. The pH value should be controlled within the range of 6.2-8.8, with a deviation not exceeding ± 1.0; The deviation of loading quantity should be controlled within 0% -10% of the indicated value. For inactivated sampling tubes, it is necessary to verify the virus inactivation efficiency to ensure a killing rate of ≥ 99%.
Microbial indicators: total aerobic bacteria count ≤ 200 CFU/mL, total mold and yeast count ≤ 100 CFU/mL. Some standards use color indicators (such as phenol red) to visually monitor microbial contamination. When the liquid turns from red to yellow, it indicates a decrease in pH value and needs to be stopped immediately.
Testing method: Visual inspection is used for appearance, universal measuring tools are used for size measurement, sealing is tested by vacuum negative pressure gauge, and membrane filtration method is used for microbial limit. All tests must be conducted in CMA certified laboratories to ensure data compliance.