On the morning of 9th March, Lan Wen, deputy minister of Fujian Provincial Industry and Information Technology Department, Zheng Gaochun, deputy section chief of Fujian Provincial Industry and Information Technology Department, Luo Jun and Zou Yongfa of Fujian Provincial Party Committee publicity Department, Cai Dejin, director of Haicang Industry and Information Technology Bureau, Wu Jingsong, deputy director of Xiamen Radio Administration Bureau visited Xiamen Innodx to implement field investigation on the product development and industrialization of the medical device registration certificate for the first Novel Coronavirus (2019-nCOV) antibody diagnostic kit in our province.
General Manager Sun Xudong of Xiamen Innodx introduced in detailed that 2019 n-Cov Ab diagnostic kit combines Nano Paramagnetic Particles and Chemiluminescent Microparticle Immunoassay technology, uses double antibody sandwich method to detect the novel coronavirus total antibody in human plasma or serum. This reagent diagnostic kit extracts blood samples, and detects in the closed environment with automatic chemiluminescent analyzer, effectively preventing cross infection during operation. And it can get detection result within 29 minutes with a high flux volume of 200 tests per hour.
The visiting group went to the production line of 2019-nCov diagnostic kit. At prepsent the monthly production capacity was over 1 million tests, and nearly 90,000 human samples were donated to Tongji Hospital, Wuhan Union Hospital, Huoshenshan Hospital, Leishenshan Hospital, Hubei CDC, Zhongnan Hospital, Xiantao Hospital, Shenzhen Third Hospital and The First Affiliated Hospital of Zhejiang University for clinical trial and clinical evaluation. General Manager Sun Xudong also introduced that novel Coronavirus test products, such as 2019-nCOV IgM/IgG antibody diagnostic reagent and 2019-nCOV antigen diagnostic reagent, were being developed by the company team and the team of National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD) of Xiamen University, which would also be launched. The company had applied to the government for a plot of more than 50,000 square meters to build the Xiamen Luminescence Production and R&D Integrated base, including the follow-up research and industrialization upgrading of Novel Coronavirus test products, to help prevent and control the epidemic by focusing on both research and production.