FDA authorizes first at-home test that can detect flu, Covid-19; check details
By Team Newsable | First Published Feb 25, 2023, 12:36 PM ISTWhile doctors have been reluctant to allow patients to conduct testing at home, the Covid-19 pandemic has changed some of that sentiment. Studies have found that people don't need medical training to test themselves for respiratory illnesses.
The US Food and Drug Administration (FDA) on Friday (February 24) authorized what it says is the first at-home test that can tell users if they have the flu and/or COVID-19.
According to reports, the test uses a single self-collected nasal swab and can provide results in about half an hour. The test was made by California biotech company Lucira Health. The test can be bought without a prescription. It's authorized for anyone 14 and older for self-collection, or an adult can give it to a child 2 or older.
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The test is able to identify a negative result for influenza A with more than 99 percent accuracy and a positive result with more than 90 percent accuracy. It's 100 percent accurate for negative Covid-19 samples and more than 88 percent accurate for positive results.
It is reportedly said that there were not enough influenza B cases while Lucira was testing the product to measure that performance, so the company says it will have to do a real-world test when there is enough virus in circulation. But in lab studies, it caught nearly 100% of negative cases.
Negative results should be confirmed with a lab test, the FDA said, "if necessary for patient management."
Studies have shown that an at-home test can be less accurate than a lab test because users might not get enough of a sample for a valid result. Health-care providers also may have more sensitive tests.
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People who have flu or Covid-like symptoms but test negative may have a different kind of respiratory infection and should get follow up care.
While doctors have been reluctant to allow patients to conduct testing at home, the Covid-19 pandemic has changed some of that sentiment. Studies have found that people don't need medical training to test themselves for respiratory illnesses.
Although the intensity of the pandemic has slowed and cases are declining, the US still had 236,131 new cases, 2,407 deaths and an average of 3,461 hospitalizations this week, according to the US Centers for Disease Control and Prevention. Seasonal flu activity is low nationally, the CDC says.
Covid-19 and flu tests are helpful as both illnesses can be treated with different medications, and those drugs work best when taken as soon as possible after symptoms begin.
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