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FDA authorizes first rapid Covid-19 self-testing kit for at-home diagnosis

November 18, 2020. Summarized by summa-bot.

The US Food and Drug Administration has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.

(CNN)The US Food and Drug Administration has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test available by prescription for self-diagnosis of the coronavirus, the agency said Tuesday.

The rapid test utilizes a molecular amplification technology to detect the virus in people with known or suspected Covid-19 and can return results in 30 minutes, the FDA said.

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Dr. Stephen Hahn said in a statement.

The new test, which uses self-collected nasal swab samples, is authorized for people 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.

It is also authorized for use in point-of-care settings, such as doctor's offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said.

"Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options," Azar said in a statement.

The self Covid-19 home test could be one more step that gets the country closer to a new normality.

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