FDA authorizes second at-home rapid COVID-19 test
The Food and Drug Administration (FDA) on Tuesday announced the emergency use authorization of another at-home COVID-19 test, signaling the potential for tens of millions of tests to be made available in the U.S. as shortages continue.
A test manufactured by Siemens Healthineers was granted authorization less than a week after Roche announced that a test it distributes, which is made by SD Biosensor, was greenlit by the agency.
“Increasing Americans’ access to easy-to-use, reliable COVID tests is a top priority for the Biden Administration, and we are using all resources at our disposal to make more tests available and ramp up supply,” Health and Human Services Secretary Xavier Becerra said in a statement.
“Adding two new authorized tests will give Americans more options for testing at home, which helps keep people safe and provides peace of mind,” he continued.
In her letter of authorization, acting chief FDA scientist Jacqueline A. O’Shaughnessy wrote that it was “reasonable” to conclude that the Siemens test was “effective in diagnosing COVID-19” and that the benefits outweighed any risks.
The test is administered on a nasal swab collected within seven days of symptoms arising. However, the at-home test is unable to differentiate between severe acute respiratory syndrome (SARS) and COVID-19, or SARS-CoV-2, O’Shaughnessy noted.
“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. 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,” O’Shaughnessy wrote.
Earlier this year, President Biden committed to purchasing a half-billion at-home COVID-19 tests to be distributed to Americans for free. These tests are expected to be sent out beginning in January.
The authorization of these tests comes as the U.S. grapples with a testing shortage amid a surge in new cases driven by the spread of the omicron variant. Biden acknowledged this week that there are “clearly not enough” available tests.
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