Tsinghua University announced on Saturday that a more sensitive COVID-19 testing kit developed by the university has been approved for commercial use, and can detect 15 variants including Delta and Omicron, reducing the error rate in ascertaining positive cases.
Zhou Yong, a professor from Tsinghua University, said that the new kit leveraged digital PCR technology, which can digitally display virus data, greatly improving the sensitivity and accuracy of nucleic acid detection.
The approval of the new kit marks the first Class III medical device certificate approved by the National Medical Products Administration for nucleic acid testing targeting the new variant, based on digital PCR technology, and is also the first research project in the world to be approved for applying digital PCR technology toCOVID-19 testing.
In response to the emergence of a number of COVID-19 variants, the university’s R&D team completed bioinformatic analysis of variant sequences and conducted validation experiments on mutations that may potentially affect the performance of the new kit.
In addition, the approved kit is expected to play two important roles in clinical research, including monitoring the clinical treatment of COVID-19 patients as well as the evaluation of anti-viral drugs in clinical studies.
A medical worker checks the bar code of a testing kit for COVID-19 screening at a residential area in Dongchang District of Tonghua, northeast China’s Jilin Province, Jan. 25, 2021. Tonghua on Monday launched the third round of citywide nucleic acid testing. (Xinhua/Xu Chang)
