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First test to self-assess covid-19 at home authorized

To travel to Spain you may need proof of covid-19 2:46

. – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first covid-19 self-test that can provide quick results at home.

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

The rapid test uses molecular amplification technology to detect the virus in known or suspected COVID-19 cases and can deliver results in 30 minutes, the FDA said.

A molecular test for covid-19 looks for signs of the genetic material of the coronavirus.

“While home-collection covid-19 diagnostic tests have been licensed, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Dr. Stephen Hahn said in a release.

The new test

The new test, which uses nasal swab samples collected by the users themselves, is licensed for people over the age of 14 with suspected Covid-19 and people under the age of 13 when performed by a healthcare provider.

It is also licensed for use in doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages, but must be administered by a health care provider, the FDA said.

“This new testing option is an important diagnostic advance in addressing the pandemic and reducing the public burden of disease transmission,” Hahn added.

Health and Human Services Secretary Alex Azar agreed.

“Making it possible for Americans to perform their own rapid covid-19 self-test at home with a prescription is the latest addition to our ever-expanding arsenal of covid-19 testing options,” Azar said in a statement.

They ask for caution

But some health experts urged caution.

“The data is still coming out,” Tom Bollyky, director of the global health program and senior fellow for global health, economics and development at the Council on Foreign Relations, told CNN. “Obviously, with some previous emergency use authorizations, it is worth being careful what the FDA has posted here, but it is certainly a promising sign.”

The covid-19 home self-test could be one more step that brings the country closer to a new normal.

“Expand the tests and make them faster, that could really be another tool that brings us back to a life that is closer to normal. If we are able to identify at least, maybe even on a daily basis, what our current viral load is and help us to be safer and that others are, “he said.

The new self-test kit includes a sterile swab, sample vial, test unit, batteries, and a plastic bag for disposal.

The sample collected on the nasal swab is inserted into the vial which then enters the test unit where it is analyzed. Results are displayed on the test unit by a color change in the LEDs, according to the FDA. Instructions on how to use the test are included with the recipe.