2nd At-Home Rapid COVID Test Is Authorized by the FDA
- 2 years ago
2nd At-Home Rapid COVID Test , Is Authorized by the FDA.
The U.S. Food and Drug Administration (FDA) announced its authorization on Dec. 28.
The test was designed by Siemens Healthineers and can now be used in addition to the Roche test the FDA also recently approved.
The authorization comes as test shortages have wracked the nation amid record-breaking numbers of infections.
Officials with the
Biden administration praised
the FDA's move as in keeping
with its COVID priorities.
Increasing Americans' access to easy-to-use, reliable COVID
tests is a top priority for the
Biden Administration, , Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
... and we are using all resources at our disposal to make more tests available and ramp up supply, Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
With daily infections topping 300,000 in the U.S., at-home testing has become a signature administration strategy.
Adding two new authorized tests will give Americans more options for testing at home, , Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
... which helps keep people safe and provides peace of mind, Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
FDA officials cautioned
that the at-home test is
not 100 percent accurate.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. , Jacqueline A. O’Shaughnessy, FDA Scientist,
via 'The Hill'.
Despite this, the tests
offer reliable guidance
in the context of a person's
potential exposure to COVID-19.
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Jacqueline A. O’Shaughnessy, FDA Scientist,
via 'The Hill'.
The Biden administration is expected to begin distribution of 500 million at-home tests sometime in January
The U.S. Food and Drug Administration (FDA) announced its authorization on Dec. 28.
The test was designed by Siemens Healthineers and can now be used in addition to the Roche test the FDA also recently approved.
The authorization comes as test shortages have wracked the nation amid record-breaking numbers of infections.
Officials with the
Biden administration praised
the FDA's move as in keeping
with its COVID priorities.
Increasing Americans' access to easy-to-use, reliable COVID
tests is a top priority for the
Biden Administration, , Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
... and we are using all resources at our disposal to make more tests available and ramp up supply, Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
With daily infections topping 300,000 in the U.S., at-home testing has become a signature administration strategy.
Adding two new authorized tests will give Americans more options for testing at home, , Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
... which helps keep people safe and provides peace of mind, Xavier Becerra, Health and Human Services Secretary, via 'The Hill'.
FDA officials cautioned
that the at-home test is
not 100 percent accurate.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. , Jacqueline A. O’Shaughnessy, FDA Scientist,
via 'The Hill'.
Despite this, the tests
offer reliable guidance
in the context of a person's
potential exposure to COVID-19.
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Jacqueline A. O’Shaughnessy, FDA Scientist,
via 'The Hill'.
The Biden administration is expected to begin distribution of 500 million at-home tests sometime in January