FACT SHEET FOR INDIVIDUALS Coronavirus

Abbott Diagnostics Scarborough, Inc. Updated: April 4, 2022 Disease 2019

BinaxNOW™ COVID-19 Antigen Self Test (COVID-19)

You are provided this Fact Sheet because you obtained What is the BinaxNOW™ COVID-19 Antigen Self
the BinaxNOW™ COVID-19 Antigen Self Test for testing Test?
yourself or dependants for the proteins from the virus The BinaxNOW™ COVID-19 Antigen Self Test is a type
that causes COVID-19. The intended use of this test is of test called an antigen test. Antigen tests are designed
for testing individuals within 7-days of symptom onset or to detect proteins from the virus that causes COVID-19
individuals with or without symptoms or other in anterior nasal swabs.
epidemiological reasons to suspect COVID-19 when
tested twice over three days with at least 24 hours but The BinaxNOW™ COVID-19 Antigen Self Test is
no more than 48 hours between tests.. intended for the qualitative detection of the nucleocapsid
protein antigen from SARS-CoV-2 from individuals within
This Fact Sheet contains information to help you 7-days of symptom onset or individuals with or without
understand the risks and benefits of using this test for symptoms or other epidemiological reasons to suspect
the detection of proteins from the virus that causes COVID-19 when tested twice over three days with at
COVID-19. After reading this Fact Sheet, if you have least 24 hours but no more than 48 hours between tests.
questions or would like to discuss the information
provided, please talk to your healthcare provider. What are the known and potential risks and benefits
of the test?
Potential risks include:
For the most up to date information on COVID-19 • Possible discomfort or other complications that can
please visit the CDC Coronavirus Disease 2019 happen during sample collection.
• Possible incorrect test result (see below for more
(COVID-19) webpage:
information).
https://www.cdc.gov/COVID19
Potential benefits include:
• The results, along with other information, can help
What is COVID-19? your healthcare provider make informed
COVID-19 is caused by the SARS-CoV-2 virus which is recommendations about your care.
a new virus in humans causing a contagious respiratory • The results of this test may help limit the spread of
illness. COVID-19 can present with a mild to severe COVID-19 to your family and others in your
illness, although some people infected with COVID-19 community.
may have no symptoms at all. Older adults and people
of any age who have underlying medical conditions have What does it mean if I have a positive test result?
a higher risk of severe illness from COVID-19. Serious If you have a positive test result, it is very likely that you
outcomes of COVID-19 include hospitalization and have COVID-19 because proteins from the virus that
death. The SARS-CoV-2 virus can be spread to others causes COVID-19 were found in your sample.
not just while one is sick, but even before a person Therefore, it is also likely that you may be placed in
shows signs or symptoms of being sick (e.g., fever, isolation to avoid spreading the virus to others. There is
coughing, difficulty breathing, etc.). A full list of a very small chance that this test can give a positive
symptoms of COVID-19 can be found at the following result that is wrong (a false positive result). If you test
link: https://www.cdc.gov/coronavirus/2019- positive with the BinaxNOW™ COVID-19 Antigen Self
ncov/symptoms-testing/symptoms.html.
Test you should self-isolate and seek follow-up care with
your healthcare provider as additional testing may be

• Where can I go for updates and more information? The most up-to-date information on
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition,
please also contact your healthcare provider with any questions/concerns.
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 FACT SHEET FOR INDIVIDUALS Coronavirus
Abbott Diagnostics Scarborough, Inc. Updated: April 4, 2022 Disease 2019
BinaxNOW™ COVID-19 Antigen Self Test (COVID-19)

necessary. Your healthcare provider will work with you to less sensitive than other COVID-19 tests and false
determine how best to care for you based on your test results may occur, repeated testing may identify more
result(s) along with your medical history, and your individuals with COVID-19 than a single test. By
symptoms. repeating testing, it may be possible to more quickly
identify cases of COVID-19 and reduce spread of
What does it mean if I have a negative test result? infection. Additional testing with molecular COVID-19
A negative test result means that proteins from the virus test may be necessary, depending on your individual risk
that causes COVID-19 were not found in your sample. factors and test results.

It is possible for this test to give a negative result that is It is important that you work with your healthcare
incorrect (false negative) in some people with COVID- provider to help you understand the next steps you
19. This means that you could possibly still have COVID- should take.
19 even though the test is negative. The amount of
antigen in a sample may decrease the longer you have What are the differences between antigen tests and
symptoms of infection. In symptomatic people, other COVID-19 tests?
specimens collected after you have had symptoms for There are different kinds of tests for COVID-19.
more than five days may be more likely to be negative Molecular tests (also known as PCR tests) detect
compared to a molecular assay. genetic material from the virus. Antigen tests detect
proteins from the virus. Antigen tests are very specific for
If you test negative and continue to experience COVID- the virus, but are not as sensitive as molecular tests.
19 like symptoms of fever, cough and/or shortness of This means that a positive result is highly accurate, but a
breath you should seek follow up care with your negative result does not rule out infection.
healthcare provider. For example, your healthcare
provider may suggest you need another test to If your test result is negative, you should discuss with
determine if you have contracted the virus causing your healthcare provider whether an additional molecular
COVID-19. If you are concerned about your COVID-19 test would help with your care, and when you should
status after testing or think you may need follow up discontinue home isolation. If you will not have an
testing, please contact your healthcare provider. additional test to determine if you are contagious, the
CDC currently recommends that you should stay home
The performance of this test was established based on until three things have happened:
the evaluation of a limited number of clinical specimens.
The clinical performance has not been established in all • You have had no fever for at least 24 hours (that
circulating variants but is anticipated to be reflective of is one full day of no fever without the use of
the prevalent variants in circulation at the time and medicine that reduces fevers)
location of the clinical evaluation. Performance at the AND
time of testing may vary depending on the variants • Other symptoms of COVID-19 are improving (for
circulating, including newly emerging strains of example, when your cough or shortness of
SARSCoV-2 and their prevalence, which change over breath has improved) **Loss of taste and smell
time may persist for weeks or months after recovery
and need not delay the end of isolation
What is serial testing? AND
Serial testing is when a single person is tested for
COVID-19 more than once. Because antigen tests are

• Where can I go for updates and more information? The most up-to-date information on
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition,
please also contact your healthcare provider with any questions/concerns.
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 FACT SHEET FOR INDIVIDUALS Coronavirus
Abbott Diagnostics Scarborough, Inc. Updated: April 4, 2022 Disease 2019
BinaxNOW™ COVID-19 Antigen Self Test (COVID-19)

• At least 10 days have passed since your

symptoms first appeared.

For more information, the CDC has provided guidelines

on how to prevent the spread of COVID-19 if you are
sick: https://www.cdc.gov/coronavirus/2019-
ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf.

Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the
United States FDA. FDA may issue an Emergency Use
Authorization (EUA) when certain criteria are met, which
includes that there are no adequate, approved, available
alternatives. The EUA for this test is supported by the
Secretary of Health and Human Service’s (HHS’s)
declaration that circumstances exist to justify the
emergency use of in vitro diagnostics for the detection
and/or diagnosis of the virus that causes COVID-19.
This EUA will remain in effect (meaning this test can be
used) for the duration of the COVID-19 declaration
justifying the emergency use of in vitro diagnsotics,
unless it is terminated or authorization is revoked by
FDA (after which the test may no longer be used).

What are the approved alternatives?

There are no approved available alternative antigen tests.
Any tests that have received full marketing status (e.g.,
cleared, approved), as opposed to an EUA, by FDA can
be found by searching the medical device databases
here: https://www.fda.gov/medical-devices/device-
advice-comprehensive-regulatory-assistance/medical-
device-databases. A cleared or approved test should be
used instead of a test made available under an EUA,
when appropriate and available. FDA has issued EUAs
for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#2019-ncov.

• Where can I go for updates and more information? The most up-to-date information on
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition,
please also contact your healthcare provider with any questions/concerns.
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