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Active infection test for COVID-19

This type of test helps to diagnose whether you currently have an active SARS-CoV-2 (COVID-19) infection. A diagnosis can guide you and your doctor or healthcare provider to make an informed decision about self-isolating to protect your family and friends.

High accuracy and reliability

Due to its high accuracy, active infection molecular testing (eg, PCR) usually does not need to be repeated.  

Other COVID-19 test options

COVID-19 testing statements

  • The Quest Diagnostics molecular test and other authorized molecular tests (together the “molecular tests”) have not been FDA cleared or approved;
  • The molecular tests have been authorized by FDA under an EUA for use by authorized laboratories;
  • The molecular tests have been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and,
  • The molecular 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 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.



Make an appointment

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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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