The first new crown detection reagent based on digital PCR technology has obtained the registration certificate of class III medical devices

In January 17th, Beijing new Yi Biotechnology Co., Ltd. (hereinafter referred to as "Xin Yi bio") announced that its independent research and development New Coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method) was officially approved by the State Administration of drugs (NMPA) medical device approval (National weapon registration: 20223400015). This is NMPA's first approval of the new crown detection reagent based on digital PCR technology. It is also the first officially approved product in the world to test the digital PCR technology in the field of infectious diseases. This means that this new technology is self controllable and further mature. It is reported that the product is jointly developed by Xinyi biology, Tsinghua University, many hospitals and CDC, and produced by Xinyi manufacturing technology (Beijing) Co., Ltd., a wholly-owned subsidiary of Xinyi biology. Digital PCR technology, known as "the third generation PCR technology", improves the sensitivity and accuracy of nucleic acid detection. Different from fluorescence quantitative PCR, digital PCR does not need standards. The PCR reaction system is divided into tens of thousands of micro droplets by microfluidic technology, and the number of target nucleic acid molecules is directly obtained by single molecule amplification.