This at-home kit tests for COVID-19 and influenza without invasive swabs or having to visit an in-person test site.
This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Learn more about the Emergency Use Authorization and Patient Fact Sheet