Abnova Completes COVID-19 Viral Antigen Rapid Test US Clinical Study, Sensitivity 100% and Specificity 96%.

Neihu, Taiwan (December 08, 2020)

Abnova announced today that It has completed the COVID-19 viral antigen rapid test US clinical study for FDA EUA, CE-IVD, and Taiwan EUA submission. The diagnostic testing of COVID-19 has quickly evolved from nucleic acid to antibody to viral antigen testing since the beginning of pandemic. Viral antigen testing has come into light as the key driver to control the infectivity and transmission of COVID-19 outbreak. The spike increase in the number of infected cases worldwide has catapulted the demand for the viral antigen rapid test.

Abnova’s COVID-19 viral antigen rapid test starts with taking a nasal swab sample, washing a lysis buffer, and applying to a chromatographic lateral flow with nanoparticle conjugated COVID-19 detecting antibody and pre-printed capture antibody on a nitrocellulose membrane. This simple yet technically demanding platform allows the detection of the COVID-19 viral particles which resides in the nasal epithelial cells. To be effective as a weapon for transmission control, Abnova’s rapid test has achieved a sensitivity of 100% which matches completely with the RT-PCR gold standard control which is currently the most sensitive test.

Abnova’s COVID-19 viral antigen rapid test’s preclinical and clinical data are being submitted to the FDA for EUA approval. At the same, the data is being translated and organized for CE-IVD and Taiwan EUA submission. So far in the US, all the companies which have gained FDA EUA approval have been from US domestic companies. There is a great business opportunity for a company which can break through this entry barrier. Currently approved COVID-19 viral antigen rapid test supply in the US from BD, Quidel, and Abbott have not met the rapid increase in market demand; this imbalance also exists worldwide.