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Nov 1, 2023 · The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, including information on expiration dates, who can use the test, links to...
- Frequently Asked Questions
Diagnostic tests can show if you have an active COVID-19...
- Emergency Use Authorization
On January 31, 2022, FDA approved the Moderna COVID-19 ......
- Year-Month-Day
15-month to 22-month shelf-life extension granted by the FDA...
- Quidel Corporation
Tests with this printed expiration date (Year -Month -Day)...
- In Vitro Diagnostics EUAs
Since the Secretary’s declaration under section 564 of the...
- Frequently Asked Questions
Apr 7, 2024 · Rapid home COVID-19 tests are accurate about 80% of the time in people who are infected with the virus that causes COVID-19. This is compared to PCR tests, which are accurate about 95% of the time. The FDA has approved a wide variety of at-home COVID-19 tests.
Jan 14, 2022 · The Ellume COVID-19 Home Test was the “first over-the-counter (OTC) fully at-home diagnostic test for COVID-19” authorized by the FDA, the agency’s press release in December said. Both the...
May 4, 2021 · The issue with home tests is accuracy, which is between 85% and 95% for detecting covid. That is, they catch about nine of every 10 infections, a metric called the test’s “sensitivity.”...
- Antonio Regalado
Sep 7, 2023 · Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.
Jan 3, 2022 · Some of the at-home rapid antigen tests have an overall sensitivity of roughly 85 percent, which means that they are catching roughly 85 percent of people who are infected with the virus and...