China launched a "more sensitive" kit approved for marketing, which can accurately detect Delta and Omi kerong

Beijing, January 15 (China News Service) (Reporter Gao Kai) 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 tsinghua University School of Medicine and Beijing Xinyi Biotechnology Co., Ltd. and other units has officially obtained the approval of the State Drug Administration (NMPA) medical devices.

According to reports, the new kit effectively improves the detection sensitivity and can 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.

Guo Yong 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, and its sensitivity can reach 100 copies/mL.

For example, he said, the TV sets in the older generation often appear "snowflakes", the picture quality is blurred, and the stability is not high. But this is not the case with the current LCD TV, because the SIGNAL of the LCD TV is a digital signal rather than the previous analog signal. Digital PCR can improve the sensitivity and accuracy of nucleic acid testing, which is similar.

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. (End)