U.S. Authorizes Additional COVID-19 Tests
The U.S. Food and Drug Administration confirmed on April 7, 2022, it had authorized two new over-the-counter (OTC) at-home COVID-19 antigen tests.
The emergency use authorizations (EUA) were issued to Osang LLC for their OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card.
As of April 8, 2022, 428 tests and sample collection devices have been authorized under EUAs during the COVID-19 pandemic.
These include 294 molecular tests and sample collection devices, 84 antibody and other immune response tests, and 50 antigen tests.
There are 74 molecular authorizations and one antibody authorization that can be used with home-collected samples.
And there is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen OTC at-home tests, and 3 for molecular OTC at-home tests.
Additionally, the FDA has authorized 28 antigen tests and nine molecular tests for serial screening programs.
The FDA has also authorized 923 revisions to EUA authorizations.
As of April 10, 2022, about 852 million tests have been reported to the U.S. CDC.
An updated test news listing is posted at this weblink.
Note: The FDA information was edited for clarity and manually curated for mobile readers.