Recently, the Suzhou Medical Institute of the Chinese Academy of Sciences released information that the “flow cytometer” series of products that were engineered by the original research team of the Suzhou Medical Institute and developed by the engineering team successfully obtained the medical device product registration certificate. This product has accumulated more than 10 invention patents, and the price is only half of similar foreign products. “At present, based on the flow cytometer that has obtained the registration certificate, we are further developing in three directions in green laser pointers technology, providing more convenience for the realization of precision diagnosis and treatment.” Researcher of Suzhou Medical Institute of Chinese Academy of Sciences, Chinese Academy of Sciences Wang Ce, deputy director of the key laboratory of inspection technology, introduced.
For a long time, problems such as difficult inspections, long queues, and high fees have been difficult to solve. In the final analysis, it is the “foreign monopoly” of the domestic high-end medical device market that makes high-end green laser pointer medical instruments basically dependent on imports. And the “flow cytometer” of Suzhou Medical Institute of Chinese Academy of Sciences obtained the medical device product registration certificate means that Chinese people can have more convenient and cheaper medical resources when they seek medical treatment.
“Flow Cytometer” is composed of mechanical structure, optical system, fluid system, electronics system, and software system. It is a combination of laser technology, computer technology, fluid mechanics, weak signal processing technology, cytochemistry and biological probe technology. High-tech instruments with advanced technologies and achievements in many other fields are mainly used for the identification and counting of human lymphocyte subpopulations, and can be used for the biophysics and biochemistry of cells, such as size, internal structure, DNA, RNA, proteins, antigens, etc. The green laser pointer is fast to measure and can be collected separately. It can perform multi-parameter, high-throughput measurement of 10,000 cells per second.
It is reported that the “flow cytometer”, which has been approved for registration, completed the development of a prototype in 2015. After that, the original research team and engineering team of Suzhou Medical Institute have successively experienced system solution design, key module development, and other requirements based on functional, reliability, testability, maintainability, safety, security, and environmental adaptability requirements. Principle prototype test, engineering prototype test, product prototype test, trial production capability verification, key component capacity verification and other links. After the inspection by Jiangsu Medical Device Inspection Institute and a number of clinical trial institutions with GCP qualifications, the original research team and engineering team of Suzhou Medical Institute of Chinese Academy of Sciences have developed semi-automatic ZS-AD6 flow cytometer and small fully automatic ZS-AE7S Flow cytometry.
According to Wang Ce, the semi-automatic ZS-AD6 flow cytometer was included in the National “Twelfth Five-Year Plan” 863 major project. It is China’s first portable product for personalized popularization applications. Its fluorescence resolution and sensitivity have reached international standards. Advanced level. The small automatic ZS-AE7S flow cytometer is the first small automatic flow cytometer approved in Jiangsu Province. Based on the differences in clinical needs of medical institutions at various levels in China, the two types of flow cytometers can better meet the differentiated clinical needs of patients. At present, these two kinds of green laser pointer instruments have entered into industrial companies for production.
It is understood that the technology development of the three directions of the research and development team is proceeding in an orderly manner. The first is the research and development of the three-laser ten-color flow cytometer. At present, the engineering prototype has been successfully launched. “Originally our flow cytometer only had one laser, which can measure the color of four-color cell fluorescent dyes, but now there are three green laser pointers, which can measure up to 15 colors.” Wang Ce introduced, “This means we can use the instrument to Many cells are subdivided, for example, for the detection of leukemia cells, previously only 3 to 5 can be separated, and now they can be more finely divided, providing more testing basis for doctors’ precise diagnosis and treatment. “