WASHINGTON (AP) – The first home test for COVID-19 that does not require a prescription will soon be on U.S. store shelves.
U.S. regulators on Tuesday cleared the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important – albeit gradual – step in efforts to expand testing options.
Regulators granted emergency use for a similar home test last month, but it needs a prescription.
The agency’s action on Tuesday allows sales in places like pharmacies “where a patient can buy it, dab their nose, get tested and get their results in as little as 20 minutes,” the commissioner said. of the FDA Stephen Hahn, in a statement.
Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume has said it plans to produce 3 million tests next month before ramping up production in the first half of 2021.
A company spokesperson said the test would cost around $ 30 and would be available at drugstores and for purchase online.
The kit includes a nasal swab, a chemical solution and a test strip. The test digitally connects 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 emphasized the need for rapid and widespread home testing so people can test for themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab from a health worker who must be processed in high-tech labs. This usually means days of waiting for results. About 25 tests allow people to take their own sample at home – a nasal swab or saliva – but then they are shipped to a lab.
Ellume’s test looks for viral proteins released by COVID-19, which is different from benchmark tests that look for the genetic material of the virus.
Like other tests that look for proteins, FDA officials have noted that Ellume’s test can provide a small percentage of false positives and false negatives. People who test negative but show symptoms of coronavirus should follow up with a medical professional, the agency said.
Currently, the United States tests nearly 2 million people daily. Most health experts agree the country needs to run several times more tests, and Harvard researchers have pushed for cheap paper home tests.
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Still, Harvard’s Dr Michael Mina called the new test a “great addition” to existing options, although he warned that its price could limit access.
“This is an important step, with reservations,” Mina said in an email. “I just hope that doesn’t create more of a wedge between the haves and have-nots.”
For people with insurance, federal law requires plans to cover the cost of the COVID-19 test.
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