Coronavirus: US FDA authorises first COVID-19 self-testing kit
"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.
FollowNew York: The US 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.
"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.
The United States is now home to more than 11 million coronavirus cases, with the latest one million cases coming at breakneck speed in the last week alone, according to Johns Hopkins Covid-19 data. The US death toll has gone past 2,46,000 on November 15.
More than 45 states are seeing record spikes during the pandemic's winter surge. Hospitals are at capacity in several states and doctors are pleading with Americans to hunker down because the "vaccines are coming, it's just a matter of a couple of months."
Based on current trajectory, America is hurtling towards an ominous coronavirus toll of more than 4,00,000 by next Spring, according to new projections from a predictive model used often by data crunchers in Donald Trump's White House coronavirus task force.
