SILVER SPRING, Md.,
Dec. 4, 2020 /PRNewswire/
-- Today, the U.S. Food and Drug Administration authorized the
first diagnostic test for at home collection of patient samples to
detect both COVID-19 and influenza A and B (flu). The FDA
authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for
prescription use with the Quest Diagnostics Self-Collection Kit for
COVID-19 +Flu by individuals who are suspected of respiratory viral
infection consistent with COVID-19 when home collection is
determined to be appropriate by an individual's healthcare
provider. Under a health care provider's order, patients can
collect a sample at home and ship it to a Quest Diagnostics
laboratory for analysis following the instructions included with
the self-collection kit.
"Today's authorization for a COVID-19 plus flu test using
samples collected at home is a significant step toward FDA's
nationwide response to COVID-19. With the authorization of this
test, the FDA is helping to address the ongoing fight against
COVID-19 while in the middle of the flu season, which is important
for many, including the most vulnerable of Americans. This is
another example of the FDA working with test developers to bring
important diagnostics to Americans," said FDA Commissioner
Stephen M. Hahn, M.D. "With just one
swab or sample, combination tests that are authorized for use with
home-collected samples can be used to get answers to Americans
faster, in the comfort and relative safety of their home, which
allows patients to continue to quarantine while awaiting results.
This efficiency can go a long way to providing timely information
for those sick with an unknown respiratory ailment."
Additional Resources:
- Novel Coronavirus
- Emergency Use Authorization: Coronavirus
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.
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SOURCE U.S. Food and Drug Administration