Tsinghua University released news on the 15th that the new coronavirus (2019-nCoV) nucleic acid detection kit (fluorescence PCR method) jointly developed by the team of Professor Guo Yong of the School of Medicine of Tsinghua University and Beijing Xinyi Biotechnology Co., Ltd. and other units officially obtained the approval of the State Drug Administration (NMPA) medical devices.
Xinyi Bio said that the kit effectively improved the detection sensitivity and could reduce the positive missed test. In addition, this "smell-sensitive" "new crown detector" will not miss detection and off-target for the 15 most common variants in the world, including Delta and Omicron.
The picture comes from the WeChat public account of Tsinghua University
The reporter learned that this is the approval of the first new crown detection reagent based on digital PCR technology of the State Drug Administration, and it is also the world's first test product that has been officially approved after review to apply digital PCR technology to the field of infectious diseases. This means that this new technology is autonomously controllable and further matured.
Professor Guo Yong of Tsinghua University School of Medicine is one of the developers of the kit. He said that the new kit uses digital PCR technology (the third generation of PCR technology), on the basis of the previous fluorescence quantitative PCR (second generation PCR technology), with the help of microfluidic biochips, digital display of new coronavirus data, greatly improving the "signal-to-noise ratio" of nucleic acid detection, its sensitivity can reach 100 copies / mL.
"For example, the TV sets in the older generation often have 'snowflakes', and the image quality is not high in fuzzy stability, but this situation does not exist in the current LCD TV, because the LCD TV signal is a digital signal instead of the previous analog signal." Digital PCR can improve the sensitivity and accuracy of nucleic acid testing, which is similar. Professor Guo Yong said.
With the complexity of the global pandemic and the emergence of new coronavirus variants, can this kit be effectively responded to? According to reports, in view of the emergence of many mutant strains of the new crown virus, the R & D team has completed the biological information analysis of the corresponding mutant strain sequences, and carried out verification experiments on mutations that may potentially affect the detection performance of reagents.
In addition, the approved kits are also expected to play two important roles in clinical research - monitoring the clinical treatment of COVID-19 patients and clinical research evaluation of anti-COVID-19 drugs.
The approval of the new kit is the first Class III medical device certificate approved by the State Food and Drug Administration for nucleic acid detection of the new crown virus based on digital PCR technology, and it is also the world's first research result that has been officially approved after review to apply digital PCR technology to the field of new crown. This progress is believed to mean that this technology is localized and autonomously controllable. For the entire technical field, the official approval of the new crown nucleic acid detection reagent based on digital PCR technology can promote the updating and iteration of this technology and rapid progress.
Editor: Mengmeng Zhao
