The US Federal Food and Drug Administration (FDA) Wednesday approved a test that can be done at home quickly, without a doctor’s prescription, and will soon be sold at the NATIONAL Drug Administration for 30 yuan. This is another important breakthrough in amplification detection.
Last month the regulator approved the urgent use of similar home tests, but only with a doctor’s prescription.
“After the 15-day approval, home tests will be available at drug administrations and other locations,” FDA Commissioner Stephen Hahn said in a statement. “People will be able to go in and fix a nasal test themselves, and they will know the results in 20 minutes.”
Approved over-the-counter tests will be available in limited quantities at first, with Australian manufacturer Ellume expecting to produce 3 million units next month and ramp up production in the first half of 2021; The test costs 30 yuan and can be bought in stores and online, a company spokesman said.
The test kit includes a nose swab, a chemical solution and a test strip; The test suite is linked to a smartphone, where the results are displayed through the App, then explained further, and users can contact experts through the app.
In recent months experts have stressed the need for rapid and extensive home testing to allow people to screen themselves out of contact with others, but most tests still need to be carried out by professionals and must be processed by high-tech laboratories, often waiting days for results. About 25 tests allow people to collect their own samples (nasal contents or saliva) at home and send them to a laboratory.
The Ellume test detects the release of toxic proteins. The standard test for medical workers is to detect the genetic material of the virus.
The Ellume test, like many tests for proteins, produces some false results, and people with COVID-19 symptoms should still seek medical attention if they test negative, FDA officials said.
Currently, nearly two million people are being tested every day in the United States. Most experts agree that testing should be expanded. Researchers at Harvard University have pushed for cheap paper home tests. Michael Mina, a Harvard University expert, said the newly approved home tests would help a lot, but warned that prices could limit usage. Federal law requires health insurance to cover the cost of COVID-19 testing.
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