US approves first rapid home Covid-19 test
Nov 18, 2020 - 12:38 PM
WASHINGTON — The US issued an emergency use authorization for the first self-administered rapid coronavirus test Tuesday, as more parts of the country increase restrictions in an attempt to halt a Covid-19 surge.
The Food and Drug Administration approved a testing kit for people age 14 and older whom a doctor suspects to have Covid-19. The test, which is by prescription only, delivers results in 30 minutes.
“We continue to demonstrate unprecedented speed in response to #COVID19,” tweeted FDA commissioner Stephen Hahn.
“FDA authorized the first #COVID19 test that’s fully self-administered & provides results at home. It’s an important advancement, underscoring our commitment to expanding test access.”
The authorization is for an at-home nasal sample kit developed by Lucira Health. Users collect a sample with the included nasal swab, then put the sample in a small vial.
The vial is inserted into a small device that tests the sample. A light-up display on the device shows a user’s result in 30 minutes or less.
The test is designed to be affordable and is intended to cost less than $50, according to the Lucira Health website.
The FDA had previously approved at-home Covid-19 tests, giving the green light in late April and early May to two nasal sample collection kits and one saliva sample collection kit.
But samples from those kits had to be sent to a lab for processing, instead of delivering results at home.
While the Lucira test provides results on the spot, it still isn’t the kind of cheap and rapid antigen test that some researchers have called to use for large-scale population screening.
As of Tuesday, the US had recorded 11,340,563 coronavirus cases with 248,429 deaths, according to Johns Hopkins University. Both tolls are by far the worst in the world.