BINAXNOW COVID -19 ANTIGEN SELF TEST

bbott BinaxNOW COVID-19 Antigen Self Test Kit (2 Tests) The only antigen test approved by the Massachusetts Department of Public Health for bypassing travel quarantine* Detects active COVID-19 infection Get results in 15 minutes Follow illustrated step-by-step instructions Perform simple test procedure using a minimally invasive nasal swab Know your result now, without the need to wait for results from your healthcare provider Finally: a fast, proven and trusted COVID-19 test that is readily available to the public. Simply purchase at a retail store near you and perform the test in the comfort and convenience of your home, with results in 15 minutes. This product is the same test that has been used by healthcare professionals nationwide since August 2020, and is now be available over-the-counter. This 15-minute self-test can be completed anytime, anywhere using a simple nasal swab and easy to follow step-by-step instructions. This test, which is packaged with two tests per box, is indicated for serial testing. Simply test yourself twice within 3 days, with at least 36 hours between tests. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as BinaxNOW, detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result tends to be accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. The self-test is indicated for children as young as 2 years old when samples are collected by an adult, and for all people 15 and older. The BinaxNOW COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.