brentryanjohnson
commented
4 years ago This question probably addresses the issue:
Q: Are there any tests that I can purchase to test myself at home for COVID-19?
A: At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers on this goal. You can find listings of tests that have received an Emergency Use Authorization (EUA) as well as labs and manufacturers that have notified FDA as set forth in the FDA\'s Policy for Diagnostic Tests for Coronavirus Disease-2019.
vbitzer
This question may cause confusion. It seems to be addressing home testing, but it implies there are no tests for COVID-19. Thoughts @vbitzer or @abbeykos?
Q: Is there a test for COVID-19?
A: Currently there is no FDA-approved or cleared test to diagnose or detect COVID-19 because the virus that causes COVID-19 is new. Therefore, the FDA has issued several Emergency Use Authorizations (EUAs) for the use of new diagnostic tests to detect the SARS-CoV-2 virus, which causes COVID-19. During public health emergencies declared under section 564 of the FD&C Act, the FDA is able to issue EUAs when certain criteria are met that allows for the use and distribution of potentially life-saving medical products to diagnose, treat, or prevent the disease, which can include diagnostic tests.