The FDA on Tuesday authorized the first at-home coronavirus test people can buy without a prescription, a step that public health experts say adds a key new tool to the United States’ arsenal for combating the pandemic.
The 20-minute antigen test, made by Australia-based manufacturer Ellume, can be used by people 16 or older and children over the age of two when a sample is collected by an adult.
Public health experts have advocated for widely distributing these rapid over-the-counter antigen tests to millions of households, arguing near-instant results would enable people to quarantine quickly after becoming infectious. The FDA is expected to authorize additional over-the-counter Covid-19 tests in the coming weeks that could bolster supply, according to industry sources.
How it works: People taking the test use a medium-length nasal swab to collect a sample. The test correctly identified 100 percent of negative samples and 96 percent of positive samples from people with symptoms when compared to lab-based tests, according to Ellume. In people without symptoms, it identified 91 percent of positive samples and 96 percent of negative samples.
The FDA cautions that asymptomatic people who receive a positive result from the test should get a second test to confirm whether they are infected, especially if Covid-19 is not prevalent in their community.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” FDA medical device director Jeff Shuren said in a press release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
-------------------------------- We are all visitors to this time, this place. We are just passing through. Our purpose here is to observe, to learn, to grow, to love… and then we return home. - Australian Aboriginal proverb
Bazootiehead-in-training
Posts: 37929 | Location: Somewhere in the middle | Registered: 19 January 2010
I'm looking forward to getting a bunch of these - hopefully, they will be cheap and plentiful. The only problem I see is the trust that people will self-report...
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Posts: 7556 | Location: chicagoland | Registered: 21 April 2005