On March 6, China's State Drug Administration (SDA) granted emergency approval to the 2019-nCoV test kit (chemiluminescent immunoassay ). This kit has been jointly developed by the XMU research team led by Prof. Xiao Ningshao and Xiamen Innovax Biotech CO., LTD. This is the world's first approved reagent using the technique of double-antigen sandwich-based enzyme-linked immunosorbent assay (ELISA).
On the strength of ELISA to detect and measure Covid-19 total antibodies (including varied antibodies like IgM, IgG and IgA) in the serum specimen, this test kit features higher sensitivity, specificity, and meanwhile it also has the advantages of being fully automatic and high-throughput and being able to run the test anytime and yield results in 29 minutes, which can significantly improve the detection efficiency of frontline medical institutions. The kit has been put into production in Xiamen Biomedical Port, with a monthly capacity to provide tests for more than 1 million, and it can be further expanded up to 6 million per month where necessary.
Source: School of Public Health