Abnova and AsiaGen Taiwan Set First Phase COVID-19 IgM IgG Rapid Test Production Target to 25,000 Tests Per Month

Neihu, Taiwan (April 17, 2020)

Abnova announced today the it has set the first phase COVID-19 IgM IgG rapid test production target with AsiaGen Taiwan to 25,000 tests per month. Abnova is completing the clinical study for European CE-IVD submission in middle of May, and has also submitted a pre-EUA (Emergency User Authorization) for US FDA review. However, in order to accommodate the increased worldwide demand, Abnova has speared ahead working closely with AsiaGen Taiwan to achieve this production target by May.

AsiaGen Taiwan specializes in GMP manufacturing of qualitative strip-based, rapid test, and has recently moved into a new facility in Tainan to increase its production output. Both companies are also evaluating the feasibility of 100,000 rapid tests monthly output based on production infrastructure and market demands. As a condition for reopening the community since COVID-19 outbreak lockdown, government authorities in each countries are considering using the IgM IgG rapid test to segregate the normal versus the infected and recovered populations.

During the clinical studies, Abnova has observed that antibody response to COVID-19 spike (S) protein does not cover entire repertoire of the COVID-19 immune antibodies. While S1 protein domain (particularly the RBD segment) is responsible for the neutralization antibody, patients also mount an immune response to the nucleoprotein (N) as an evidence of COVID-19 infection. As a second generation rapid test product, it would be ideal to develop a multiplex assays using all the different COVID-19 proteins for assessing all IgM and IgG antibody response.