On Mar 26, Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) from CapitalBio Technology aquired CE-IVD certificate. The kit is jointly developed by CapitalBio Corporation, Tsinghua university and West China Hospital，Sichuan University. It could detect six kinds of respiratory virus including 2019-nCoV. Its CE certificate indicates that the product fully complies with EU’s medical device requirements and gainis access into the EU market. It would provide powerful diagnosis tools to EU regions for prevention of COVID-19 pandemic.
Besides the Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) which focuses on virus detection, CapitalBio Technology also has two products aquired CE certificates: Respiratory Pathogens Nucleic Acid Detection Kit (Isothermal Amplification on Disk Chip), and the equipment RTisochip™ Isothermal Nucleic Acid Amplification Microfluidic Chip Analyzer. They acquired CE certificate in 2016 and 2017 respectively. Now the three CE-certified products could fully cover the fast diagnosis of nucleic acid from bacteria and virus.