Vivera’s Chief Medical Officer Dr. McColgan on Tucker Carlson
CBS discussing COVID–19 Rapid Testing
This test is distributed under the revised May 2020 Guidance set forth by FDA. An Emergency Use Application has been submitted and the Vivera Pharma COVID-19 Rapid Test is currently on the FDA’s List “Manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D” found at the following link: FDA Notification List.
We are proud to work with FDA and NCI in their quest to provide independent third party validation.
THIS TEST IS NOT FOR THE SCREENING OF DONATED BLOOD.
THIS TEST HAS NOT BEEN REVIEWED BY THE FDA.
FOR PROFESSIONAL USE ONLY IN QUALIFIED CLIA CERTIFIED HIGH COMPLEXITY SETTINGS.
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 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.
© 2020 Vivera Pharmaceuticals, Inc.