NO MORE BARRIERS. NO MORE INCONVENIENCES. ANSWERS, WHEN AND WHERE YOU NEED THEM.

COVID-19 testing will remain an important tool as our global communities continue to experience seasonal waves of COVID-19. The BinaxNOW COVID-19 Self Test is identical to the professional-use test card, used since August 2020, and is the most studied and widely available rapid antigen test.

 

With BinaxNOW authorized for over-the-counter 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 at your local retailer over the counter self-test, or from your healthcare professional. This combination increases access to quick, simple, affordable and reliable testing options.

 

No more lines, no more wait times, no more barriers and no more inconveniences. Answers are now in your hands.






THE FUNDAMENTALS

The Latest on BinaxNOW
COVID-19 Self Tests 

NAVICA APP SUPPORTING COVID-19 TESTING
NAVICA APP SUPPORTING COVID-19 TESTING
NAVICA APP SUPPORTING COVID-19 TESTING

OUR MISSION

  

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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.