Sure Bio-Tech API Covid-Rapid is Registered by the FDA. Covid-Rapid is Available for Sale to Medical Providers Only. Not for home use.
Updated US FDA guidance issued on March 16, 2020 allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. This test is not intended for home use and must be used under the prescription of a licensed professional. All positive tests should be reported to your local health department. This will help local and state officials understand the breadth and depth of the epidemic and may help guide public policy decision making. This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been recently in contact with the virus or are high risk. Testing with a molecular diagnostic should be considered to rule out infection in these individuals. Patients should care for themselves and those around them by continuing to quarantine for another few days. 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.