WASHINGTON D.C. — A rapid, at-home COVID-19 test that can be purchased over the counter without a prescription will be available on store shelves soon.
Regulators authorized the test, which can be done entirely at home.
“The test will be sold in places like drugstores,” FDA Commissioner Stephen Hahn said, “where a patient can buy it, swab their nose, run the test and find out the results in as little as 20 minutes.”
Emergency use for a similar home test was approved last month, but does require a doctor’s prescription.
The test comes from the Australian manufacturer Ellume and supplies are expected to be limited, as the company expects to produce 3 million tests next month before ramping up production in the first half of 2021.
The company said the test will be priced around $30 and be available at pharmacies and for purchase online. The kit will include a nasal swab, a chemical solution and a testing strip.
The test will connect digitally to a smart phone app that displays the results and helps to interpret the results. Users will have access to health professionals via the app as well.
The U.S. is currently testing nearly 2 million people per day.
Ellume’s test seeks out viral proteins shed by COVID-19 instead of looking for the genetic material of the virus.
The FDA said that the test can still deliver a small percentage of false positive and false negative results. Patients who get a negative result, but have COVID-19 symptoms should follow up with a health professional.
A release date for the tests has not been announced.