This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is 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.
Antigen tests are couple percent less sensitive than PCR-based laboratory methods and their clinical performance depends on the circumstances in which they are used. The Centers for Disease Control and Prevention (CDC) have released guidance for rapid antigen testing for SARS-CoV-2. FDA and CDC guidance suggest that antigen test results should be considered in the context of clinical observation, patient history, and epidemiological information.
A positive test result when the person is symptomatic or has been exposed to COVID-19 indicates that SARS-CoV-2 antigen was detected and that the individual is very likely infected and considered a COVID-19 case. Positive individuals should be isolated.
Discover the fast, proven and trusted COVID-19 antigen test that is readily available over-the-counter at retailers across the country. Purchase the BinaxNOW™ COVID-19 Antigen Self Test at a retail store near you and perform the test with a simple nasal swab in the comfort and convenience of your home.
- SIMPLE AND EASY TO USE: Requires just a shallow nasal swab that you can do yourself; includes easy-to-follow instructions.
- SEE RESULTS IN 15 MINUTES: Convenient, fast results anytime, anywhere; no need for a prescription or send to a lab.
- FOR AGES 2 TO ADULT: Indicated for children as young as 2 years old when administered by an adult, and for all people 15 and older to self-administer.
- DETECTS ACTIVE COVID-19 INFECTION: Includes 2 tests that are indicated for serial testing—simply test yourself twice within 3 days, at least 36 hours apart; designed to detect active infection with or without symptoms. Detects multiple strains, including the DELTA variant.
- FOR PERSONAL USE: This test does NOT meet the CDC testing requirements to enter the U.S. when returning from a trip abroad. For proof of negative COVID-19 test, the BinaxNOW COVID-19 Ag Card Home Test may be a better choice.
Here’s How the Apply the BinaxNOW COVID-19 Antigen :
- Prepare for the test
- Collect nasal sample, or help others administer if they require assistance
- Perform the test
- See results after 15 minutes
- Test again within three days (with at least 36 hours between tests)
Refer to product insert for full instructions.