Beroni Group has been added to the list of Commercial Manufacturers and Laboratories which have notified the U.S. Food and Drug Administration (FDA) they have validated serology tests as set forth in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease – 2019.
Under this Policy, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
- This test is currently being reviewed by the FDA
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals
- Results from the antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
Beroni’s SARS-CoV-2 IgG/IgM antibody detection kit based on colloidal gold is a rapid single-use immunochromatographic test intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary “fingerstick” whole blood, plasma, and serum samples. The point-of-care test kit is intended for professional use and delivers clinical results within 10 minutes.
“With the rapid increase in the number of coronavirus cases globally, the availability of fast and effective test kits is of utmost urgency. We want to make our test kit available in the U.S. and other markets as soon as possible to combat the exponential growth of the coronavirus infections,” Jacky Zhang, Chairman and CEO of Beroni Group, said.
Beroni will continue to consult with the FDA about qualifying the test kit under FDA’s Emergency Use Authorization. The Company has already obtained the CE mark approval for the test kit and will be distributing the product in the European Union market.