U.S. FDA approves 1st coronavirus self-testing kit for at-home use

Posted November 17, 2020 10:33 pm

The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

Read more: Canada adds 4,275 new coronavirus infections as total cases top 306K

“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 Stephen Hahn said.

The kit can also be used at hospitals but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

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Coronavirus: Second wave hitting hard across Canada

Coronavirus: Second wave hitting hard across Canada

At home testing has not been authorized in Canada.

A post on Health Canada’s website says the agency has “authorized the sale and importation of COVID-19 tests only for use by health care professionals or trained operators.”

“However, we are open to reviewing all testing solutions,” the website reads. “This includes approaches that use self-testing kits, to enable individuals with or without symptoms to assess and monitor their own infections status.”

-With files from Global News

© 2020 Reuters