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COVID-19 Self-Testing Enters Main-Street

The U.S. FDA recently announced it had authorized 419 tests and sample collection devices during the COVID-19 pandemic. And the home antibody testing option has been embraced by people everywhere.

This table lists FDA-authorized at-home COVID-19 diagnostic tests and includes links instructions for each test. 

The FDA confirmed on Feb. 24, 2022, serology or antibody test measures the number of antibodies present in the blood like the SARS-CoV-2 coronavirus.

SARS-CoV-2 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from COVID-19. However, antibody tests should not be used to tell you if you have an active COVID-19 infection.

At this time, SARS-CoV-2 antibody tests do not tell you if you:

  • currently have COVID-19, the disease caused by the SARS-CoV-2 virus,
  • have immunity that will prevent COVID-19,
  • need a COVID-19 vaccine, or
  • if your COVID-19 vaccine worked.

However, a positive SARS-CoV-2 antibody test does not necessarily mean you are immune or have immunity that will prevent COVID-19.

And, SARS-CoV-2 antibodies detected in your blood reflect only one part of your immune system, including T-cells and other components that are part of your body's immune response, says the FDA.

The FDA also updated the question and answer resources for COVID-19 Test Development and Review and Test Uses.

Additional coronavirus test news is posted at CoronavirusToday.com/test.