FDA OKs 1st rapid virus test that allows results at home

The at-home kit administers what's known as a molecular diagnostic test — which searches for the virus's RNA fingerprint.

News 12 Staff

Nov 18, 2020, 10:32 PM

Updated 1,346 days ago

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The FDA has approved the first at-home coronavirus test.
The FDA granted emergency authorization to the 30-minute test kit from Lucira Health.
The at-home kit administers what's known as a molecular diagnostic test — which searches for the virus's RNA fingerprint.
Dr. Ankita Sagar, with Northwell Health, says this could be a game changer for people worried about infecting others and those who can't easily get to a testing site.
"We think a lot about patients who may be staying at home for different reasons because they're responsible for caring for others in their home or they cannot leave the home because they're frail or elderly," said Sagar.
That type of test is considered by health care experts to be more accurate than an antigen test, which looks for viral proteins instead.
According to Lucira Health, its product was compared to one of the most reliable high sensitivity COVID-19 tests available.
In that study, the Lucira test was shown to be 94.1% accurate at detecting positive results, and 98% accurate at finding negative results.
Patients would need a prescription to get the kit, which requires users to swab their own nose, and then stir the sample into a vial before the results are displayed.
If there is any doubt about the at-home test's results, Sagar says a second test would be in order.
"When it says you do not have COVID-19 but you have symptoms that sound like COVID-19, we would do a follow-up test with the traditional, gold standard PCR, the test that takes a couple of days to come back," said Sagar.
The at-home rapid test kit would cost around $50 and will initially be rolled out on a limited basis in Northern California and south Florida. But the company says it's expected to be available nationally by early spring of next year.


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