BinaxNow
A simple solution for COVID-19 infection detection.
New over-the-counter COVID-19 antigen test
Introducing a new over-the-counter COVID-19 antigen test that has received FDA Emergency Use Authorization for self-testing without the need for a prescription from a healthcare professional.
This test, which is packaged with two tests per box, is indicated for serial testing. Customers will simply test themselves twice within 3 days, with at least 36 hours between each test. By testing more frequently, customers may detect COVID-19 more quickly and reduce the spread of infection.
AN OVER-THE-COUNTER TEST FOR COVID-19
INFECTION DETECTION
Detects active COVID-19 infection
• Get results in 15 minutes
• Follow illustrated step-by-step instructions
• Perform the simple test procedure using a minimally invasive nasal swab
• Know your result now, without the need to wait for results from a healthcare provider
What is Emergency Use Authorization (EUA)?
FDA emergency access mechanism.
• Health and Human Services declares when circumstances exist to justify the use of diagnostics under the EUA during public health emergencies.
• It is not full FDA clearance or approval and is temporary until the declaration is terminated or revoked.
What is serial testing?
Serial testing involves testing the same individual multiple times within a few days and can increase the chances of detecting asymptomatic infection that may not always show up with a single test.
Is it a requirement to perform both (2) tests?
Yes, per the product labeling, both tests must be done over 3 days, with at least 36 hours between tests.
If the first test is positive, then proteins from the virus that causes COVID-19 have been found in the specimen and the person likely has COVID-19. They should self-isolate and seek follow-up care with their healthcare provider to determine next steps. Additional testing may be needed, depending on the person’s personal health history and other factors.
Does this test detect the new variants?
Abbott is intently monitoring the mutations of COVID-19 so we can ensure our tests can detect them, as we do with many viruses. We have conducted a thorough analysis of known variants that we’ve been able to study, and we are confident that our tests remain effective at identifying these strains.
How is the test administered?
Using the BinaxNOW COVID-19 Antigen Self Test is simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deeper nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box. You will also need a timer/watch and it is recommended that gloves are worn during testing. Each test kit will include an illustrated quick reference guide that provides step-bystep instructions on how to use the test.
Who should use this test?
The test can be used for people with and without symptoms..
Should people who were vaccinated use this test?
BinaxNOW will be a key tool alongside vaccination as we get back to life. We don’t yet know how long the vaccine confers immunity for and how variants will evolve.