[Image from unsplash.com]
A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.
The FDA has authorized five at-home COVID-19 testing kits 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 it can be confirmed by another test. 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 molecular diagnostics, antibody and antigen test and collection kits. 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 as well, which has led the FDA to warn on some tests and revoke emergency use authorization from others.
Of the over 300 diagnostic tests, 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.