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.
“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.
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