COVID-19 and influenza have similar symptoms, making it difficult to determine what you have. Using a single nasal swab, BinaxNOW™ COVID-19/Flu A&B simultaneously tests for COVID-19, influenza A and influenza B, with results in 15 minutes.
BinaxNOW COVID-19/Flu A&B detects multiple COVID-19 variants and Flu strains.
BinaxNOW COVID-19/Flu A&B is HSA/FSA eligible. Please reach out to your health insurance provider to determine reimbursement eligibility and whether your HSA/FSA account can be used to purchase the test.
The Control, as well as COVID-19 and Flu A lines (if present) will be RED, and the Flu B line (if present) will be BLUE. The line for Flu B is BLUE as it is intended to help the user distinguish between Flu B, Flu A and COVID-19.
Yes, you will need a timer/watch. Disposable gloves and a mask are recommended if testing other individuals.
No, the nasal swab should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.
An anterior nasal swab sample can be self-collected by individuals aged 14 years and older. Children aged 2 to 13 years should be tested by an adult. Do not use on anyone under 2 years of age.
Each product box has an expiration date and should not be used after that date.
No, serial testing (or repeat testing), does not need to be performed if you have a positive or negative result at any time.
Antigen tests, such as BinaxNOW COVID-19/Flu A&B Combo Self Test, detect proteins from the virus, while molecular tests detect genetic material 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, Flu A, and/or Flu B than a molecular test would.
No, this test only detects an active infection.
BinaxNOW COVID-19/Flu A&B should be stored in a location between 36°F and 86°F until use. At the time of use, the test and its components should be used at room temperature.
People are encouraged to follow the latest CDC guidelines for reporting results. BinaxNOW COVID-19/Flu A&B Combo Self Test is only for personal use and does not provide a verified result.
No, this test is indicated for use with symptomatic individuals only.
No, this test does not require a prescription from a medical professional. However, if you have questions about your health or the results of your test, you should contact a healthcare professional.
No, though if you exhibit symptoms of a respiratory infection you should seek follow up care with your healthcare professional.
After test is completed, dispose of used materials in household trash.
Our BinaxNOW COVID-19/Flu A&B Combo Self Test is simple. Each test kit includes step-by-step instructions with illustrations. You perform a minimally invasive nasal swab and all materials required to perform the test come in the box, with the exception of a timer. You can watch a video on how to do the test and see answers to top questions here: https://www.globalpointofcare.abbott/us/en/lp/binaxnow-self-test/covid-19-flu-ab-combo.html
A negative test result indicates that antigens from the virus that causes COVID-19 or influenza were not detected in your sample. If you have a negative result, it does not rule out SARS-CoV-2 or influenza 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 test result means that one, or multiple, of the viruses detected by this test were also detected in your sample. It is very likely that you have the respective COVID-19 and/or influenza infection(s) and are contagious. You should self-isolate following local guidelines. Please contact your physician or healthcare provider to discuss your test results and follow-up care. In rare instances, individuals may also have coinfections with other bacteria or viruses that this test is not designed to detect. This means that the virus detected by this test may not be the definitive or the only cause of your disease. There is a small chance that this test can give you a positive result that is incorrect (a false positive).
BinaxNOW is a rapid, visually-read lateral flow antigen test used to detect active infections of COVID-19 and Influenza A&B.
Each component within a test kit (nasal swabs, test cassettes, extraction fluid, etc.) has its own lot number and expiration date. The expiration date for the entire kit is based on the shortest dated component.
BinaxNOW COVID-19/Flu A&B is manufactured in South Korea.
The cassette format meets the manufacturing conditions for BinaxNOW COVID-19/Flu A&B. This cassette format meets the same quality and performance standards as other BinaxNOW products.
Failure to follow the instructions may result in inaccurate test results. If you think you’ve made a mistake, please perform another test with a new kit, paying close attention to the process instructions.
Swabbing both nostrils by making at least 5 circles is part of the sample collection process in order to receive accurate results.
For technical support with BinaxNOW COVID-19/Flu A&B Combo Self Test, please contact Abbott Technical Support at 1-833-637-1594.
Once opened, the test cassette should be used immediately. If left open, please use a new test before testing an individuals sample.
Any visible test line including red for COVID-19 (S), blue for Influenza B (B), and/or red for Influenza A (A) with a red control line (C) should be read as positive.
If you need further assistance please give us a call at 1-855-513-8348, 24/7, including weekends. You may also reach out to our customer support team by filling out the contact form below.
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.
BinaxNOW COVID-19 Antigen Self Test is HSA/FSA eligible. Please reach out to your health insurance provider to determine whether your HSA/FSA account can be used to purchase the test.
Serial testing means that people should test themselves frequently, so that if they’re positive, they can catch themselves at the beginning of their infection and, hopefully, before they transmit it to others.
BinaxNOW is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. You do not need to perform repeat testing if you have a positive result.
Yes, you will need a timer/watch and it is recommended that gloves are worn during testing.
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.
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use available at www.globalpointofcare.eifu.abbott
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.
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.
Please contact your health insurance provider to determine reimbursement eligibility.
Molecular tests (also known as PCR or NAAT tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result tends to be accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation.
It is up to each organization to determine what test they accept. We recommend you check with them.
The BinaxNOW™ COVID-19 Antigen Self Test is only for personal use and does not provide a verified result. Your results are read visually on the test card at least 15 minutes after the test is performed (but not more than 30 minutes).
Each product box has an expiration date and should not be used after that date.
Since the launch of the BinaxNOW™ COVID-19 Antigen Self Test, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Testing has been completed to support a shelf-life (expiration date) of up to 22 months. The BinaxNOW™ COVID-19 Antigen Self Test, part number 195-160 or 195-180, may now have a longer than labeled product expiry date. You can lookup your lot number on our website at rapidtest.abbott/binaxnow.
The BinaxNOW™ COVID-19 Antigen Self Test is only for personal use and does not provide a record of your result. Your results are read visually on the test card at least 15 minutes after the test is performed (but not more than 30 minutes).
No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.
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.
Since the launch of the BinaxNOW™ COVID-19 Antigen Self Test, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Testing has been completed to support a shelf-life (expiration date) of up to 22 months. The BinaxNOW™ COVID-19 Antigen Self Test, part number 195-160 or 195- 180, may now have a longer than labeled product expiry date. All BinaxNOW COVID-19 Antigen Self Test kits currently have a twenty-two-month expiry date.
| KIT LOT NUMBER | ORIGINAL PRINTED EXPIRATION DATE^ | EXTENDED EXPIRATION DATE |
|---|
Note: do not use LOT number on individual kit components (test cards, nasal swabs, reagent bottles, instructions, or fact sheet)
Expiration date extension information for other self-test brands can be found at the FDA website:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests
Disclaimer:
This tool is designed to offer a convenient way for consumers to lookup extended dating by lot number, utilizing information shared by Abbott with the FDA. For official information, please see the FDA letter listing BinaxNOW™ COVID-19 Antigen Self Test kit lot numbers, currently labeled kit expiry and new kit expiry date available on the FDA website at https://www.fda.gov/media/158003/download.
Since the launch of the BinaxNOW™ COVID-19 Antigen Self Test, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Testing has been completed to support a shelf-life (expiration date) of up to 22 months. The BinaxNOW™ COVID-19 Antigen Self Test, part number 195-160 or 195- 180, may now have a longer than labeled product expiry date. All BinaxNOW COVID-19 Antigen Self Test kits currently have a twenty-two-month expiry date.
| KIT LOT NUMBER | ORIGINAL PRINTED EXPIRATION DATE^ | EXTENDED EXPIRATION DATE |
|---|
Expiration date extension information for other self-test brands can be found at the FDA website:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests
Disclaimer:
This tool is designed to offer a convenient way for consumers to lookup extended dating by lot number, utilizing information shared by Abbott with the FDA. For official information, please see the FDA letter listing BinaxNOW™ COVID-19 Antigen Self Test kit lot numbers, currently labeled kit expiry and new kit expiry date available on the FDA website at https://www.fda.gov/media/158003/download.
Note: do not use LOT number on individual kit components (test cards, nasal swabs, reagent bottles, instructions, or fact sheet)
If you need further assistance please give us a call at 1-833-637-1594, 24/7, including weekends. You may also reach out to our customer support team by filling out the contact form below.
Only available in the US. Terms of Sale.
*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.
*1H 2024 Nielson Test Sales Market Data on file
**Abbott conducted a computational analysis of the detection of multiple SARS-COV-2 strains, including the OMICRON variant, and predicts no impact in the performance of our BinaxNOW COVID-19 Antigen Self Test.
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