The EUA authorizes at-home sample collection
with testing performed in a laboratory
SILVER
SPRING, Md., May 16, 2022
/PRNewswire/ -- Today, the U.S. Food and Drug Administration
authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test
for use without a prescription by individuals with symptoms of
respiratory viral infection consistent with COVID-19. This product
is the first direct-to-consumer (non-prescription) multi-analyte
COVID-19 test authorized by FDA and allows an individual to
self-collect a nasal swab sample at home and then send that sample
to Labcorp for testing. The test can identify and differentiate
multiple respiratory viruses at the same time, detecting influenza
A and B, commonly known as the flu, respiratory syncytial virus,
commonly known as RSV, along with SARS-CoV-2, the virus that causes
COVID-19. Results are delivered through an online portal, with
follow-up from a health care provider for positive or invalid test
results.
"While the FDA has now authorized many COVID-19
tests without a prescription, this is the first test authorized for
flu and RSV, along with COVID-19, where
an individual can self-identify their need for a test,
order it, collect their sample and send it to the lab for testing,
without consulting a health care professional," said
Jeff Shuren, M.D., J.D., director of
FDA's Center for Devices and Radiological
Health. "The rapid advances being made in
consumer access to diagnostic tests, including the ability to
collect your sample at home for flu and RSV without a prescription,
brings us one step closer to tests for these viruses that
could be performed entirely at home."
This home sample collection kit can be purchased online or in a
store without a prescription. The samples can be self-collected by
individuals ages 18 years and older, self-collected by individuals
14 years and older with adult supervision, or collected with adult
assistance for individuals 2 years and older. This will enable
consumers to more easily determine whether they may be infected
with COVID-19, flu, or RSV, which can aid in determining if
self-isolation (quarantine) is appropriate and to assist with
health care decisions after discussion with a health care
professional.
Media Contact: Jim
McKinney, 240-328-7305
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-available-without-a-prescription-that-also-detects-flu-and-rsv-301548268.html
SOURCE U.S. Food and Drug Administration