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 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 aged 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 and point-of-care settings 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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Although a recent string of positive news from Moderna Inc and Pfizer Inc on
their potential vaccines has raised hopes in combating the disease, testing
still is a key factor in controlling the spread of the virus.
"We look forward to proactively working with test developers to support the
availability of more at-home test options," said Jeff Shuren, the director of
the FDA's Center for Devices and Radiological Health.
The United States crossed 11 million total infections on Sunday, just eight days
after reaching the 10 million mark.
(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D'Silva)
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