The COVID-19 test kit developed by Xiamen University was approved to be launched on March 6. The test is carried by drawing blood and results can be available in 29 minutes. It also has the advantages of high sensitivity and testing at any time. It is also the first COVID-19 test kit approved for market in Fujian Province.
Xiamen University announced on March 6th that with the support of the emergency research project of the Ministry of Science and Technology and the provincial and municipal science and technology and drug supervision departments, Xia Ningshao and his team of the National Institute of Diagnostics and Vaccine Development in Infectious Diseases of Xiamen University joined hands with Xiamen Innodx Biotech Co., Ltd. in successfully developing 2019-nCoV antibody test kit (chemiluminescent microparticle immunoassay), which has been officially approved for market after the emergency examination and approval of the National Medical Products Administration. The test kit has been industrialized in Xiamen Bio Bay, Haicang District, with a monthly production capacity for more than 1 million people.
This is also the first approved total antibody test kit by double-antigen sandwich method at home and abroad. Up to now, the National Medical Products Administration has approved 10 nucleic acid test kits and 5 antibody test kits for COVID-19. The former is to directly detect virus, which imposes high requirements for sample collection. If satisfactory lower respiratory tract samples are not obtained, the sensitivity of testing with usual nasopharyngeal swabs will be insufficient. The latter is to test the specific immune reaction products (antibodies) produced by virus infection in human blood, which can be obtained by using general serum or plasma samples.
