WASHINGTON (AP) – The first homemade test of COVID-19 that does not require a prescription will soon be done on U.S. store shelves.
U.S. regulators on Tuesday authorized rapid coronavirus testing, which can be done completely at home. The Food and Drug Administration’s announcement represents another important, albeit incremental, step in efforts to expand testing options.
Last month, regulators granted emergency use for a similar test at home, but a prescription is needed.
The agency’s action on Tuesday allows it to sell in places like pharmacies “where a patient can buy it, whip their nose, do the test and know their results in just 20 minutes,” said the commissioner of the FDA Stephen Hahn in a statement.
The initial supply of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before increasing production during the first half of 2021.
A company spokesman said the test will be priced at about $ 30 and will be available at pharmacies and can be purchased online.
The kit includes a nasal swab, a chemical solution and a test strip. The test connects digitally to a smartphone app that displays the results and then helps interpret them. Users can also connect with a healthcare professional through the app.
For months, health experts have stressed the need for rapid, widespread testing at home so people can be examined and avoid contact with other people if they have an infection. But the vast majority of tests still require a nasal swab performed by a healthcare worker to be processed in high-tech labs. This usually means waiting days to get the results. About 25 tests allow people to collect their own sample at home, a nasal swab or saliva, but then send it to the lab.
The Elume test looks for viral proteins released by COVID-19, which is different from the standard gold tests that look for the genetic material of the virus.
Like other protein-looking tests, FDA officials noted that the Ellume test can provide a small percentage of false positive and false negative results. People who get a negative result but have coronavirus symptoms should be followed up with a health professional, the agency said.
The US is currently testing almost 2 million people daily. Most health experts agree that the country needs to try many more times and Harvard researchers have opted to do cheap paper tests at home.
Still, Dr. Michael Mina, of Harvard, defined the new test as “a great addition” to existing options, though he warned that its price could limit access.
“This is a milestone, with reservations,” Mina said in an email. “I just hope it doesn’t generate a wedge between those who have and those who don’t.”
For people with insurance, federal law requires that plans cover the cost of COVID-19 testing.