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A more sensitive kit developed by a Chinese team has been approved for the market to accurately detect Omicron

via:IT之家     time:2022/1/15 23:00:35     readed:168

IT Home on January 15, according to the wechat official account of Tsinghua University, Recently, the Novel Coronavirus (2019-NCOV) nucleic acid test (fluorescence PCR) jointly developed by Professor Guo Yong's team from Tsinghua University School of Medicine, Beijing Xinyi Biotechnology Co., LTD and other units has been officially approved by the National Medical Products Administration (NMPA) for medical devices.

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IT Home has learned that the approval of the new kit is the first Class III medical device certificate for novel Coronavirus nucleic acid detection based on digital PCR technology approved by the STATE Food and Drug Administration, and also the world's first officially approved research result of applying digital PCR technology in the field of COVID-19 after review. The development is thought to mean that the technology can be made locally and controlled autonomously. For the whole technology field, the official approval of the nucleic acid detection reagent for COVID-19 based on digital PCR technology can promote the update and iteration and rapid progress of this technology.

The kit adopts the third-generation PCR technology with a sensitivity of 100 copies/mL, which effectively improves the detection sensitivity and can reduce positive missed detection. Even the novel coronavirus trace in samples cannot escape detection, providing a more accurate tool for the prevention and control of COVID-19 and nucleic acid detection.

In view of the emergence of many novel Coronavirus variants, the R&D team has completed the bioinformation analysis of the sequences of the corresponding variants and carried out validation experiments for mutations that may affect the detection performance of the reagent. The kit will not miss or miss the target of the 15 most common variants in the world at present: Delta strain, Omicron strain, etc.

According to Guo, the new kit uses digital PCR (third-generation PCR) and, on the basis of fluorescence quantitative PCR (second-generation PCR), uses microfluidic biochip to digitally display novel coronavirus data, greatly improving the "signal-to-noise ratio" of nucleic acid detection. Its sensitivity can reach 100 copies/mL.

For example, he said, older people often have "snowflakes" on their televisions, which have blurred picture quality and poor stability. This is not the case with LCD TVS today, because the signal is digital rather than analog. In a similar way, digital PCR can improve the sensitivity and accuracy of nucleic acid detection.

In addition, the approved kit is 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. It not only plays a role in the front end of nucleic acid testing, but also throughout the whole process of clinical diagnosis and treatment of patients, vaccine drug development and efficacy evaluation.

According to reports, in view of the emergence of many novel Coronavirus variants, the R&D team has completed the bioinformation analysis of the sequence of the corresponding variant strains and carried out verification experiments on the mutations that may affect the detection performance of the reagent.

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