Will this Test Hurt? 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.
What is the Difference Between an Antigen and Molecular Test? There are different kinds of tests for COVID-19. Molecular tests (also known as PCR 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.
What is the performance of this Test? The BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020, bringing the most studied rapid antigen test to retail shelves across the country.
What do sensitivity and specificity mean? Sensitivity refers to a test's ability to designate an individual with disease as positive. Specificity of a test is its ability to designate an individual who does not have a disease as negative.
What ages is the test approved for use? 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.
Will my insurance reimburse this? The test is available for a low cost, overthe-counter without a prescription and is not currently covered by insurance.
Will this test tell me if I have been infected with COVID-19 in the past? No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.
Can I use this test to meet travel requirements for testing? No, this is for personal use only and doesn’t provide a documented test result that you can display when traveling. For a documented test result the BinaxNOW COVID-19 Ag Card Home Test may be a better choice. Combined with the NAVICA App and with a negative result, you will have a digital result that may meet travel requirements. This test is offered by eMed, please visit www.emed.com for further information.
Does the product expire? How long is it good for? Each product box has an expiration date and should not be used after that date.
Do I need any additional supplies to conduct the test at home? Yes, you will need a timer/watch and it is recommended that gloves are worn during testing.
What is Serial 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.
What do I need to know about Results from Serial Testing? If your first test is negative, you should test again within 3 days, with at least 36 hours between tests. If your first or second test is positive, then proteins from the virus that causes COVID-19 have been found in your specimen and you likely have COVID-19. If you test positive with the BinaxNOW COVID-19 Antigen Self Test, you should self-isolate and seek follow-up care with your healthcare provider to determine the next steps you should take. You may need additional testing, depending on your personal health history and other factors.
What is Emergency Use Authorization (EUA)? ¿ FDA emergency access mechanism. ¿ Health & Human Services declare when circumstances exist to justify use of diagnostics under EUA during public health emergencies. ¿ It is not full FDA clearance or approval and is temporary, until the declaration is terminated or revoked.
Does this test detect the new variants? Abbott is intently monitoring the mutations of COVID so we can ensure our tests can detect them, as we do with many viruses. We have conducted a thorough analysis of known variants that we’ve been able to study, and we are confident that our tests remain effective at identifying these strains. It is highly likely that future COVID-19 strains will remain detectable because our tests – and most other COVID-19 tests – look for parts of the virus that are crucial for the virus’ survival and therefore less subject to mutation.
What is the difference between this test and other COVID-19 tests that can be performed at home? The BinaxNOW COVID-19 test is the most studied test in the U.S. today. Results are available in just 15 minutes without having to send the sample away for collection. It’s easy-to-use with a minimally invasive nasal swab and is available over-the-counter without a prescription.
How many tests come in a package? The test will come in a 2-count box.
How is the test administered? Using the BinaxNOW COVID-19 Antigen Self Test is simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deeper nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box. Each test kit will include an illustrated quick reference guide that provides step-by-step instructions on how to use the test.
Who should use this test? The test can be used for people with and without symptoms.
Should people who were vaccinated use this test? BinaxNOW will be a key tool alongside vaccination as we get back to life. We don’t yet know how long the vaccine confers immunity for and how variants will evolve.
How will people report their test results if they’re positive? People are encouraged to follow the latest CDC guidelines, which is to communicate your results to your healthcare provider, who is responsible for reporting your test results to the state health department.
Why is this test indicated for “serial testing” and what does serial testing mean? 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. By having our test indicated for serial testing, it offers an added layer of protection. That’s why each box comes with two tests in it.
Do I need to perform more than one BinaxNOW COVID-19 Antigen Self Test? The BinaxNOW COVID-19 Antigen Self Test is indicated by the FDA for serial testing, meaning that people should test themselves frequently. The tests should be administered twice over three days with at least 36 hours between the two tests. When combined with vaccines and other public health precautions, frequent testing can help restore a sense of confidence as Americans get back to gathering together.
How long should people wait between taking BinaxNOW COVID-19 Antigen Self Tests? The tests should be administered twice over three days with at least 36 hours between tests.
Do people need to consult a doctor or another healthcare professional before purchasing and conducting a test? 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. If you receive a positive result, you should contact a healthcare professional for next steps.
Can more than one test be purchased at a time? The BinaxNOW COVID-19 Antigen Self Test is indicated by the FDA for frequent testing, which is why Abbott has made them available as a 2-count box.
Can people use HSA/FSA accounts to purchase the test? That’s up to individual insurance companies to determine. Some cover other Over the Counter products so individuals would need to reach out to their provider to determine coverage.
How do I swab myself for the Abbott BinaxNOW COVID-19 Antigen Self Test Kit? 1. Using the swab from the kit, insert the entire soft tip of the swab into a nostril (usually ½ to 3/4 of an inch). You do not need to go deeper. 2. Using medium pressure, rub the swab against all of the inside walls of your nostril. ¿ Make at least 5 big circles. Do not just spin the swab. ¿ Each nostril must be swabbed for about 15 seconds. 3. Using the same swab, repeat steps 1 and 2 in your other nostril.
How long does it take to get results from the BinaxNOW COVID-19 Antigen Self Test Kit? Results are obtained in 15 minutes.
Do I need a prescription or a doctor’s note to purchase the BinaxNOW COVID-19 Antigen Self Test Kit? No prescription is required.
Is BinaxNOW COVID-19 Antigen Self Test Kit accurate? Based on the results of a clinical study where the BinaxNOW COVID-19 Antigen Self Test was compared to an FDA authorized high sensitivity SARS-CoV-2 test, BinaxNOW COVID-19 Antigen Self Test correctly identified 91.7% of positive specimens and 100% of negative specimens.
Can I purchase the BinaxNOW COVID-19 Antigen Self Test Kit more than once? Yes
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