FDA authorizes cheap rapid at-home COVID-19 tests

This clears the way for large groups of people to self-test for COVID-19 and get results quickly.


The details on COVID-19 at-home testing are changing, and in a way that could have a major impact on our ability to deal with the pandemic. The FDA has now authorized multiple rapid tests for over the counter use (meaning, without a prescription or doctor pre-approval) to screen people who don't have symptoms of the disease. According to the FDA, "The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable."

The first tests cleared for at-home screening are the Quidel QuickVue and Abbott BinaxNOW COVID-19 Antigen Self Test. They had already received authorization for testing of people who already show symptoms, but now they're approved to do routine screening on a regular basis of people who don't show any symptoms. They can also be used to get negative results before people return to school or work and are around others.

The idea is that by enabling rapid testing at a mass scale that includes people who don't show symptoms of infection, we can catch cases of COVID-19 sooner, and slow down its spread. Everything people need to perform the test comes in the box, and they can be used on children as young as two years old. Abbott says its BinaxNOW test can return results in 15 minutes, and will be available online or on shelves at major retailers within the next few weeks.

Other tests gaining approval include the Abbott BinaxNOW COVID-19 Ag Card 2 test that's available for use at home with help from a telehealth proctor or at a point-of-care location, but now does not require a prescription from a doctor to administer. The BD Veritor System for Rapid Detection of SARS-CoV-2 is also approved for use at point-of-care locations.

Separately, the CDC and the National Institute of Health are trying out a rapid at-home test initiative in two communities where thousands of residents will receive kits they can use on themselves three times a week for a month. They're attempting to find out if frequent self-tests can help cut down on the spread of COVID-19, and see this as a way to gather important data in North Carolina and Tennessee. NIH Director Francis S. Collins said in a statement that "This testing initiative is the first of this scale to attempt to make free, rapid, self-administered tests available community-wide in order to determine their effectiveness in our nation’s comprehensive response to the COVID-19 pandemic."