The first home test for COVID-19 that does not require a prescription will be on U.S. store shelves soon.
US regulators on Tuesday approved the rapid coronavirus test, which can be done completely at home. The Food and Drug Administration announcement represents another important – albeit incremental – step in the effort to expand testing options.
Regulators provided emergency assistance for a similar home test last month, but it requires a doctor’s prescription.
The agency’s action on Tuesday allows for sale in places like drugstores “where a patient can buy it, wipe his nose, run the test and find out the results in just 20 minutes,” FDA Commissioner Stephen Hahn said in a statement. statement.
Initial deliveries of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production in the first half of 2021.
A company spokesperson said the test will cost about $ 30 and will be available at pharmacies and purchased online.
The kit contains 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 provider through the app.
For months, health experts have been emphasizing the need for quick, comprehensive home tests so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health professional and processed in high-tech laboratories. That usually means waiting days for the results. With about 25 tests, people can take their own sample at home – a nasal swab or saliva – but that’s then sent to a lab.
Ellume’s test looks for viral proteins that are rejected by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.
Like other tests that scan for proteins, FDA officials noted that Ellume’s test can yield a small percentage of false positive and false negative results. People who get a negative result but have coronavirus symptoms should contact a health professional, the agency said.
Currently, the US tests nearly 2 million people every day. Most health experts agree that the country should be tested many times over, and Harvard researchers have pushed for cheap, paper-based home tests.
Still, Dr. Harvard’s Michael Mina is testing the new “great addition” to existing options, although he warned that the price could limit access.
“This is a milestone, with caveats,” Mina said in an email. “I just hope it no longer drives a wedge between haves and have nots.”
For people with insurance, federal law requires plans to cover the cost of COVID-19 testing.
The Associated Press Department of Health and Science is supported by the Howard Hughes Medical Institute’s Science Education Department. The AP is solely responsible for all content.