The agency since then has authorized five at-home COVID-19 tests for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.
However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until another test can confirm it. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.
The FDA has issued EUAs for more than 300 COVID-19 tests. So far in 2021, the FDA has authorized more than 88 new diagnostic tests as the U.S. surpasses 29.5 million reported COVID-19 cases.
The innovations in testing for the SARS-CoV-2 virus over the last year have not come without their pitfalls. False positives and false negatives have been reported in a number of rapid tests for clinical use, which has led the FDA to warn on some tests and revoke emergency use authorization from others.
Of the more than 300 COVID-19 molecular diagnostics, antibody and antigen test and collection kits granted EUAs, 50 test kits are authorized for home use — with only five offering results within minutes without having to send samples to a lab.
Here are five at-home COVID-19 tests you should know more about.