BinaxNOW and NAVICA: TAKING COVID-19 TESTING TO A NEW LEVEL BinaxNOW and NAVICA: TAKING COVID-19 TESTING TO A NEW LEVEL BinaxNOW and NAVICA: TAKING COVID-19 TESTING TO A NEW LEVEL BinaxNOW and NAVICA: TAKING COVID-19 TESTING TO A NEW LEVEL
OVER-THE-COUNTER RAPID COVID-19 TESTING, IN YOUR HANDS OVER-THE-COUNTER RAPID COVID-19 TESTING, IN YOUR HANDS OVER-THE-COUNTER RAPID COVID-19 TESTING, IN YOUR HANDS OVER-THE-COUNTER RAPID COVID-19 TESTING, IN YOUR HANDS

SCALING UP ACCESS TO CORONAVIRUS TESTING

 

In this critical moment in the pandemic, testing is fundamental in our ability to help facilitate a return to work, school and life with a bit more confidence. BinaxNOW™ is a fast, reliable, affordable and portable rapid test that Abbott will produce at mass scale to greatly expand access to testing to people who need it. We ship tens of millions of tests each month and continue to ramp production.

 

We've paired this 15-minute, easy-to-use test with a mobile app, called NAVICA™, which works like a secure digital "health pass" that can be scanned to enter organizations and other places where people gather. This combination is life-changing technology that will attack the pandemic on critical fronts – speed, simplicity, affordability, access and reliability.



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BinaxNOW Ag Card Home Test:

Click here for product information on the test that allows rapid results in the safety and convenience of your home.


BinaxNOW Ag Card:

For professional use, click here for product information on the BinaxNOW COVID-19 Ag Card and the NAVICA App.

THE TECH



THE SCIENCE
FOR PARENTS AND SCHOOLS

WHAT TO KNOW ABOUT ABBOTT'S BINAXNOW™ AG CARD TEST

Abbott has been a global leader in infectious-disease testing for many decades. We’ve been dedicated to meeting health needs since long before this pandemic, and we will be for long after. The BinaxNOW COVID-19 Ag Card provides a fast and reliable tool for detecting active coronavirus infections.

WHAT IS THE BINAXNOW AG CARD?

BinaxNOW is a rapid test that detects COVID-19 antigens (the proteins that make up the virus) to help identify someone is currently infected. It is easy-to-use, provides fast results and can help healthcare professionals quickly identify infectious people so they can take measures to help prevent the spread of the disease to others.

Everything needed to perform the BinaxNOW antigen test is included in a credit-card-sized kit, which lets authorized healthcare providers (such as a school nurse) test quickly and easily.

The BinaxNOW test has been authorized by the U.S. Food and Drug Administration through its Emergency Use Authorization process and is intended to identify antigen from SARS-CoV-2 in a nasal swab. For complete information on the BinaxNOW test, visit https://www.fda.gov/media/141570/download.

WHAT IS AN ANTIGEN TEST?

Antigens, like the ones found in COVID-19, are proteins of a virus that can be detected during the infection cycle. Antigen tests can indicate high quantities of this protein in an active infection.

Because rapid antigen tests can help identify people when they are infectious and at the highest risk of spreading the disease, they can be a powerful tool, in addition to following other measures such as wearing a mask, hand-washing and social distancing.

WHY IS MY SCHOOL USING RAPID ANTIGEN TESTS?

Testing, along with other important measures such as hand-washing, social distancing and wearing masks, is fundamental to helping slow the spread of COVID-19.

Through BinaxNOW rapid antigen testing (and where applicable, our NAVICA app), schools will be able to more quickly identify those who are infectious and get them into quarantine per their protocols.

HOW DOES THE TEST WORK?

BinaxNOW is administered by a healthcare provider, such as a school nurse or a nurse practitioner or pharmacist at a retail pharmacy. Administering the test is a simple and quick process.

BinaxNOW is administered as follows:

  • A nurse or healthcare professional (HCP) will be wearing a mask and gloves to give the test, to prevent the spread of germs.
  • The nurse/HCP will open the BinaxNOW Ag Card, lay it flat on a surface, and apply drops of reagent — a chemical mixture used to detect components such as COVID-19.
  • The nurse/HCP will insert a small swab into the lower part of the nasal cavity, moving the swab slightly around both nostrils. This is a less uncomfortable experience than the longer, deeper nasal swab.
  • The nurse/HCP will then place the swab into the BinaxNOW Ag Card and twirl the swab five times.
  • In 15 minutes, the result of the test will be displayed on the front of the BinaxNOW Ag card. One line indicates negative, and two lines indicate positive.
  • The results will either be sent to the NAVICA app (where used) or used to provide a result to your school.

WHAT IS THE NAVICA APP?

NAVICA is a first-of-its-kind app, available at no charge, that is designed to complement the BinaxNOW test. If available, the NAVICA app communicates test results and allows people who test negative to display a temporary digital “pass” that is renewed each time a person is tested. The NAVICA app can be downloaded from the App Store (Apple) and GooglePlay (Android). For more information on NAVICA, visit, https://www.abbott.com/BinaxNOW-Test-NAVICA-App/NAVICA-FAQ.html.

HOW LONG IS A NEGATIVE RESULT "VALID"?

Protocols will vary by school. A negative BinaxNOW result means the test did not detect COVID-19 antigens that indicate someone is currently sick and potentially infectious. As with any diagnostic test, the result is based on a person’s health condition at the time of testing, and a negative result one day does not mean that a person might not become infectious (positive) later on.

If using the NAVICA app to display testing results, the digital pass stored in the app is designed to be temporary and expires after 7 days.

WHAT HAPPENS WITH A POSITIVE RESULT?

Protocols for notification of a positive result will vary by school.

If using the NAVICA app, after a positive test, users will also get a message that includes CDC guidelines recommending that they quarantine and see a doctor.

MY SCHOOL ISN'T USING THE NAVICA APP; HOW WILL I SHOW A NEGATIVE RESULT?

As protocols will vary by school, please reach out to your school administration.

WHAT IF MY SCHOOL IS USING NAVICA BUT MY CHILD DOESN'T HAVE A SMART PHONE?

Not having access to a mobile device shouldn’t be a barrier to attending school. While protocols will vary by school, common-sense methods can be used in lieu of the NAVICA digital pass, such as matching negative results to attendance records, offering students individual paper passes, or maintaining a paper or digital database of students and faculty who test negative.

HOW WILL STUDENTS RECEIVE ONGOING TESTS?

Protocols around testing will be determined by school.

HOW FAST ARE RESULTS AVAILABLE ON BINAXNOW?

Results are available in 15 minutes for the healthcare provider.

IS THE TEST PAINFUL?

Unlike a nasopharyngeal swab that requires the healthcare provider to insert the swab in the upper nasal cavity, these samples are taken by a nasal swab in the lower nasal cavity.

WHO WILL ADMINISTER THE TESTING AT MY SCHOOL?

This will depend on your school's protocol. Please contact an administrator for this information.

WHAT HAPPENS IF MY SCHOOL RUNS OUT OF AVAILABLE TESTS?

The federal government purchased the first 150 million Abbott BinaxNOW diagnostic tests on August 27, 2020, for distribution nationwide. Schools are developing testing protocols based on supply of testing and will determine how to administer their testing program based on testing allotment and state guidance.

WILL MY SCHOOL SHARE THE RESULTS WITH THE GOVERNMENT?

Healthcare providers in all settings are required to report COVID-19 test information and results to public health authorities, regardless of whether they use the NAVICA app. More information on the reporting requirements for COVID-19 testing is available on the Centers for Disease Control and Prevention (CDC'’s website at: https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html


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The BinaxNOW COVID-19 Ag Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

The BinaxNOW COVID-19 Ag Card Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

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