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Rapid antigen testing is a faster way to detect if you have a current COVID-19 infection. Results are typically ready in just 15 to 30 minutes.

Moving forward faster

Rapid antigen testing may be helpful for those who want quick results to meet a testing requirement for an event or travel. For example, this test can be used if you plan to visit a location or establishment that requires testing prior to arrival. Testing requirements vary by location and may change over time.

Other COVID-19 test options

a 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 COVID-19 antigen 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, and 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 Federal Food, Drug, and Cosmetic 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 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.

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Discuss with your doctor

Regardless of your test result, you should discuss your results with your doctor and continue to follow any safety precautions recommended by public health experts. This can help you and your community better manage the risks and benefits of resuming daily activities.

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