The BinaxNOW rapid antigen test is a highly portable, easy-to-use, affordable test that provides results in 15 minutes. The point-of-care Ag card allows testing at scale in CLIA-waived settings, with NAVICA app integration for easy access to results and reporting. NAVICA is a complementary app that pairs with BinaxNOW. This app allows people who test negative to have a temporary encrypted digital pass that displays their results, similar to an airline boarding pass. This allows organizations to verify negative test results—enabling people to move about with greater confidence. Each kit contains 40 individual test devices, ideal for large group settings or high volume testing sites.
- Forty (40) test cards containing the test strip
- Forty (40) sterile nasal swabs
- One (1) 7.5 ml bottle containing extraction reagent
- One (1) positive control swab
- One (1) negative control swab
- One (1) product insert
- One (1) procedure card
- 97.1% Sensitivity
- 98.5% Specificity
- Cards work extremely well with large groups of testing.
- Detection and diagnosis of both viable (live) and non-viable COVID-19 directly from nasal swabs, without viral transport media
- No need to send results to a lab
- Visual results available in 15 minutes
In the USA, this product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. 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.