Friday, February 23, 2024

FDA Steps Up In Ongoing Coronavirus Health Crisis

There is expanded and increased availability of at-home tests — a step forward in the common goal of making sure that more Americans are tested for COVID-19.

The U.S. Food and Drug Administration (FDA) announced recently a new round of updates on home coronavirus tests in the battle against COVID-19. In the same breath, the FDA announced another list of tests will be discontinued as the battle against SARS-CoV-2 enters another front against the deadly virus. There is a focused push on these serology (antibody) tests posted as recently as June 4

The FDA maintains a dedicated FAQs page, to keep both health professionals and the general public regularly informed as the COVID-19 battle continues. For this latest announcement, the FAQ’s have been updated to reflect the new available information. 

As part of the next phase, there is expanded and increased availability of at-home tests, among those commercially available — a step forward in the common goal of making sure that more Americans are tested for COVID-19. The FDA announced Emergency Use Authorization (EUA) of new in-vitro tests, as well. The newest information will provide Americans with more updates about testing, as well as other news the FDA is unveiling.

FDA Has Approved A New At-Home Test For COVID-19
Photo by Paul Biris/Getty Images

Here are the largest takeaways of the newest measures put in place by the FDA: 

Testing changes

As testing for COVID-19 improves in recognizing the virus or past virus, the FDA continues to examine test accuracy. Some tests were withdrawn because the manufacturer indicated that they were no longer available or being currently manufactured. Additionally, tests were withdrawn from use because the manufacturing company had voluntarily withdrawn its test from the EUA consideration process by the FDA. 

Serology Testing

The FDA is supportive of at-home testing and has authorized several COVID-19 tests for home collection of specimens to be sent to in-state test centers for subsequent processing and to generate test results. Under the guidelines for serology testing, manufacturers can offer their COVID-19 test for at-home self-collection if the EUA issued by the FDA governing self-collection is specifically authorized. In addition, COVID-19 tests for at-home self-collection may be used as part of an Institutional Review Board (IRB) approved study.

RELATED: What New Guidelines For Serology Testing Mean For COVID-19

According to the FDA, several states have authorized the ongoing creations of test centers to collect results for COVID-19 tests. Those states, according to the FDA online updates, are Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York and finally, Washington state. 

To date, The FDA has worked with 400 test manufacturers to develop the antibody tests, who have submitted or indicated their intent to submit EUA tests to the FDA, to help develop tests that detect the COVID-19 virus, or antibodies to the virus.

RELATED: FDA Has Approved A New At-Home Test For COVID-19

The FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.

Members of the public can submit questions about the (FDA) templates via, or they can submit comments regarding the templates to the public docket established for the guidance.


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