COVID-19

^a Positive results with the antibody test may occur after COVID-19 vaccination, but the clinical significance is not yet known. How long antibodies remain detectable after infection or vaccination and how long protection, if any, may last is not yet known. The results of this test should not be interpreted as an indication of degree of immunity or protection.

^b Rapid antigen tests are less accurate than molecular tests, so your doctor may recommend a molecular test when your antigen test result does not make sense with your symptoms and exposure history. For example, when the antigen test says you are infected, but you do not have symptoms (and have not been exposed recently). Another example is when your antigen test says you are not infected, but you have symptoms. Rapid antigen tests have their best accuracy within 7 days of symptoms starting. Accuracy and the clinical significance of results beyond the 7 days is not known.

COVID-19 testing statements

• The antibody tests, molecular tests, and antigen tests (together “All tests”) have not been FDA cleared or approved;
• All tests have been authorized by FDA under EUAs for use by authorized laboratories;
• The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
• The COVID-19 molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
• The COVID-19 and Flu test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and
• COVID-19, Flu, and RSV test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens;
• The antigen tests have been authorized only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens; and
• All tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of 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.

About the FDA Emergency Use Authorization (EUA) Status

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 IgG antibodies against 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 of 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.