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RAPID ANTIGEN TEST AND MOBILE NAVICA APP DESIGNED TO HELP RESTORE MORE CONFIDENCE IN DAILY LIFE.
BINAXNOW AG IS NOW AVAILABLE OVER-THE-COUNTER, BRINGING ACCESSIBLE COVID-19 RAPID SELF-TESTING TO THE MASSES.
Even while vaccines are rolling out, COVID-19 testing will remain crucial to helping us all return to normal as we begin to engage in everyday life once again. The BinaxNOW COVID-19 Self Test card is identical to the professional-use test card, used since August 2020, and is the most studied and widely available rapid antigen test and is now available as a Self Test.
Now, with BinaxNOW authorized for over the counter for frequent asymptomatic use, we are making testing directly available for fast results, when and where you need it. You can now access our BinaxNOW test in 3 ways: at your local retailer over the counter self-test, or proctored at-home or from your healthcare professional. This combination will help attack the pandemic on critical fronts – speed, simplicity, affordability, access and reliability.
No more lines, no more wait times, no more barriers and no more inconveniences. Answers are now in your hands.
Rolling Stones, December 21, 2022
Axios, December 16, 2022
Time, December 7, 2022
American Society for Microbiology Journal, June 28, 2022
Researchers at leading academic institutions find BinaxNOW is a reliable way to detect COVID-19 including variants.
For the professional use and at-home versions of BinaxNOW, you can receive verified tests results to your phone via our NAVICA mobile app.
Get the app before your first test.
AFFORDABILITY, RELIABILITY, ACCESSIBILITY: THE IMPACT OF BINAXNOW IN COMMUNITIES.
AS DAILY LIFE OPENS UP, CORONAVIRUS IS THE GUEST THAT WILL CONTINUE TO OVERSTAY ITS WELCOME. THAT'S WHY WE TEST.
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.
The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.
This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.
The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-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. For serial testing, the BinaxNOW COVID-19 Antigen Tests should be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test can be used.
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