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FDA authorizes first at-home Covid-19 test that gives users results quickly

The Lucira COVID-19 All-In-One Test Kit requires a prescription and works in about 30 minutes, the FDA says.
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The Food and Drug Administration has authorized the first Covid-19 test designed for users to take and develop at home for results within an hour.

The agency announced the emergency use authorization for the Lucira COVID-19 All-In-One Test Kit on Tuesday night.

The test, which requires a prescription, works in about 30 minutes, the FDA says. People swab themselves and swirl it in a vial that is then placed in a test unit. The kit is authorized for home use for patients 14 or older. It can also be used in places like hospitals for patients of any age.

FDA Commissioner Stephen M. Hahn in a statement called the kit an important advancement to help prevent the spread of the deadly disease.

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Lucira Health said the tests were expected to initially roll out in California and Florida "in the near future." The kits will then be widely available across the country in spring 2021 at a price tag of $50.

Lucira Health's at-home Covid-19 test.
Lucira Health's at-home Covid-19 test.Courtesy Lucira Health

According to Lucira Health, the tests have a sensitivity of about 94.1 percent and a specificity of 98 percent.

A test's sensitivity measures how well it identifies positive cases, and the specificity refers to how well it detects negative cases. In both cases, the higher, the better.

Other rapid tests have been granted emergency use authorization by the FDA, but this is being called the first one authorized for use at home. Some tests have also been authorized for samples to be collected at home, but those must then be sent away for testing.

Coronavirus cases have been rising across the country, and health experts have warned that there could be significant spread in the wake of the holidays and colder weather that forces more people indoors. Some states or other governments have increased restrictions in recent days to slow the virus' spread.

As of Tuesday night, more than 11.4 million cases of Covid-19 have been recorded in the United States, with more than 249,000 deaths, according to NBC News' count.

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