RAPID TEST

On March 16, the U.S. government took an unprecedented step towards access to Coronavirus Disease (COVID-19) testing by allowing developers of certain tests to commercialize the products in the U.S. without the requirement for an FDA approval or Emergency Use Authorization (EUA)i. To comply with the regulation, the following statements must be included in any test reports using the COVID-19 Rapid Test: 

• 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 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. In addition, we have included these statements throughout the product package insert, aligning with the technical sections to which they pertain.