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FDA approves at-home COVID test
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Has Achieved Nirvana
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quote:
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.”


https://www.politico.com/news/...-at-home-test-445478


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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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