INDIANAPOLIS — Roche announced a new name and brand for the COVID-19 At-Home Test – Pilot COVID-19 At-Home Test, which debuts this week nationwide.
The Pilot COVID-19 At-Home Test, the first over-the-counter test distributed in the U.S. by Roche Diagnostics, received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on December 24, 2021, and is manufactured by SD Biosensor Inc. The test has been distributed to tens of millions of Americans via the U.S. government’s efforts to expand access to testing earlier this year. It uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.² The Pilot COVID-19 At-Home Test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2.
“Great progress has been made to make COVID-19 testing easy and universal,” said Matt Sause, president and CEO of Roche Diagnostics North America. “We are excited that the Pilot test offers convenience and broad accessibility for frequent testing needs, whether for a known exposure or safety for group settings.”
With a relative sensitivity of 93.2% and a relative specificity of 100%3, the Pilot COVID-19 At-Home Test can help you determine your next step, such as self-isolation for COVID-19, seeking further testing, and pursuing advice from a healthcare professional about treatment options, or ending isolation with two confirmed negative results.
Taking an at-home COVID-19 test is recommended by the CDC when you: have any COVID-19 symptoms; were exposed to someone with COVID-19; or are going to an indoor event or gathering. If you test negative, consider repeating the test 48 hours later. Receiving multiple negative test results increases the confidence that you are not infected with the virus that causes COVID-19. If you have symptoms, although serial testing may be useful, seeing a healthcare provider should be considered because multiple viruses including the flu are currently circulating.