Recently, a portable nucleic acid rapid amplification device jointly developed by West China Hospital of Sichuan University and Chengdu Wanzhong Yixin Biotechnology Co., Ltd. has obtained the medical device registration certificate (registration certificate number: Sichuan Machinery Registration 2022222020206), which also means that this product has been approved for market launch.
nucleic acid rapid amplification device is as big as a golf ball. It is currently the smallest nucleic acid rapid amplification device on the market in China. The nucleic acid reagent card independently developed by West China Hospital is about the same size as a lighter. The two can be combined and split. The reagent card is used for one-time use, and the nucleic acid rapid amplification device can be used repeatedly and multiple times. After the nucleic acid reagent card obtains the medical device registration certificate, the two can be used together to market as a whole.
reporter learned that this portable nucleic acid rapid amplification device takes 2 or 3 hours different from the traditional PCR experimental technology. From a technical perspective, the detection time is greatly saved, the results are automatically produced in 30 minutes, and there is no time-consuming transportation process. At the same time, because of its small size, simple and easy to port, and simple operation, it can be flexibly applicable to application scenarios such as home testing, community screening, rapid inspection in public places such as airports and stations, reducing the technical dependence on professional inspectors. People without medical background can also easily complete nucleic acid nasal swab sampling and testing.
Regarding the accuracy and price of the detection, Professor Hu Wenchuang of West China Hospital of Sichuan University said: Its performance is comparable to international advanced level, the accuracy rate reaches national professional standards, and the price is expected to be within 100 yuan. Compared with similar foreign products, the cost and expenses are greatly reduced, with a decrease of 90%. At the same time, this portable nucleic acid rapid amplification device has good scalability. In addition to amplifying the new coronavirus samples, it can also be used for rapid amplification of virus samples such as influenza A, influenza B, and HPV in the future.
In March 2021, a multidisciplinary medical and industrial integration team led by Professor Li Weimin, Professor Hu Wenchuang, Professor Huang Jin, Professor Ying Binwu, etc., relying on the "Medical + Manufacturing" Center of Sichuan University, the Precision Medicine Center of West China Hospital, and the Medical Equipment Innovation Center of Sichuan University, the research and development of nucleic acid rapid self-test products based on the "Medical + Manufacturing" Center of West China Hospital, the Precision Medicine Center of West China Hospital and the Medical Equipment Innovation Center, focusing on microfluidic chip technology, and developing nucleic acid rapid self-test products. At the same time, West China Hospital jointly carried out standardized clinical research with many units including Sichuan Provincial Center for Disease Control and Prevention, Sichuan University West China Guang'an Hospital, Chengdu Public Health Clinical Medical Center, and other units, and completed the verification of hundreds of clinical samples.
