Before initiating the test, it is important to first read and closely follow the detailed instructions included in the package. The BinaxNOWTM COVID-19 Antigen Self Test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*
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Capture your results in NAVICA for self‑reporting.
Find a test kit (contains 2 tests) at your local retailer.
Complete your test, or help others administer if they require assistance.
Wait 15 minutes and view the results.
Follow the Instructions for Use regarding serial, or repeat, testing.
If you use the NAVICA app, your results will be automatically reported to public health authorities. Your results will also be available in your result history in NAVICA, where you can print, share and refer back to as needed. If you receive a positive COVID-19 test result, you should consult with your healthcare provider and follow CDC guidelines, in addition to quarantining yourself.
You can self report up to 2 test results a day, per profile in NAVICA.
No, when the foam end of the swab is inserted, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.
There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19.
Molecular tests detect genetic material from the virus. Antigen tests, such as the BinaxNOW COVID-19 Antigen Self Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card was compared to an FDA authorized high sensitivity SARS-CoV-2 test and correctly identified 84.6% of positive specimens and 98.5% of negative specimens.
Antigen tests have demonstrated positive percent agreement as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive) in an independent study conducted by the National Institutes of Health.1
The BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020.
The test is indicated for all people aged 15 years or older and for children as young as two years old when samples are collected by an adult.
Please reach out to your health insurance provider to determine whether your HSA/FSA account can be used to purchase the test.
Please contact your health insurance provider to determine reimbursement eligibility.
No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.
No, this is for personal use only and doesn’t provide a documented test result that you can display when traveling. For documented results, consider using a proctored or teleheath-led self test, or contact your healthcare professional.
Each product box has an expiration date and should not be used after that date.
However, BinaxNOW COVID-19 Antigen Self Test expiration dates have been extended. Download the Extension Letter for more information.
The tests should be stored in a location between 35.6° and 86°F until use. However, if the test is stored outside the temperature range for a short period of time - for a couple of hours up to a day or two, it will still be okay to use. At the time of use, the test and its components should be used at room temperature.
Yes, you will need a timer/watch and it is recommended that gloves are worn during testing.
COVID-19 Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms and received a negative result, you should test at least two more times with 48 hours in between tests for a total of three tests. If you have a negative result, it does not rule out SARS-CoV-2 infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take. A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result.
Abbott is intently monitoring the mutations of COVID so we can ensure our tests can detect them, as we do with many viruses. Abbott has conducted a computational analysis of the detection of multiple SARS-CoV-2 strains, including the Delta and Omicron variants and predicts no impact to the performance of our BinaxNOW COVID-19 Antigen Self Test.
*The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARSCoV-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 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.
†Abbott conducted a computational analysis of the detection of multiple SARS-COV-2 Strains, including the DELTA and OMICRON variants, and predicts no impact to the performance of our BinaxNOW™ COVID-19 Antigen Self Test.
1. FDA Letter: Revisions Related to Serial (Repeat) Testing for the EUAs of Antigen IVDs. November 1, 2022. Accessed January 26, 2023. https://www.fda.gov/media/162799/download
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