This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while Quest Diagnostics has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA-cleared or -approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use on in vitro diagnostics 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.

Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.

This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while Quest Diagnostics has validated the test and has the data to believe the test is accurate, this test has not been FDA-cleared or -approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use on in vitro diagnostics 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.

Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.