Product Manual

HOW DO I GET THE MOST ACCURATE RESULTS?
The best way to obtain accurate results is to follow the
directions for nasal swab collection and test procedure
exactly as described in the Scanwell App.
WHAT SHOULD I DO IF MY PHONE BATTERY RUNS OUT
DURING THE TEST?
It is important to make sure that your phone is charged
or charging before beginning the test. If your phone
runs out of battery power after starting the test and
the app quits, your test kit will be marked as used and
the test cannot be restarted.
WHAT SHOULD I DO IF MY PHONE CANNOT CONNECT TO
THE INTERNET?
The Scanwell App requires an internet connection (either
WiFi or cellular) to login, start the test, and upload results.
If you lose internet connection while testing, you can
continue and complete the test. Your results will be
stored on your phone and will be visible in your Test
History. However, your results will not be uploaded to
Scanwell’s server. This means that if you delete the app
or login on a dierent phone, you will not be able to see
those test results.
• Follow the Scanwell Health App directions exactly
as presented. Failure to do so may affect test
performance and/or produce incorrect results.
• Leave the swab inside its packaging until instructed
to swab the nose. Keep the swab clean. Do not allow
anything to touch the soft tip of the swab until
instructed to swab the nose.
• Perform the test as soon as possible after swabbing
both nostrils, but no more than 1 hour after
swabbing and within 30 minutes after adding the
swab to the Tube.
• You must apply the 3 drops of sample to the marked
location on the test stick within 5 minutes of opening
the test stick packaging.
• Keep the test stick on a flat, well-lit surface during
the test. Take care not to drop the test stick.
• Do not use the test if the liquid in the tube spills.
• Stay near your smartphone during the 15 minutes
the test is running so you can hear the timer alarms.
The Scanwell Health App will generate timing alerts
during testing that are important to hear.
• Scan the test stick as soon as the 15-minute alert
sounds. You have 5 minutes to complete your scan
after the end of the 15-minute incubation, or the test
becomes invalid.
• Do not force quit the Scanwell Health App until your
result is available.
• Do not attempt to determine test results visually.
Only use the Scanwell Health App, on a smartphone,
to determine test results.
• Use only the contents provided in the test kit.
• This is a one-time use kit. Do not reuse any test kit
components.
• Do not use this test kit beyond the expiration date
printed on the outside of the box.
• Do not use if any of the test kit contents or
packaging is damaged.
• The tube liquid contains sodium azide. Do not inhale,
swallow, or expose to skin. If the liquid contacts skin,
wash immediately with plenty of soap and water.
If the liquid contacts eyes, flush with plenty of water.
Do not flush the tube liquid down the drain.
Warnings & Precautions
5
WHAT DOES IT MEAN IF I HAVE A POSITIVE
TEST RESULT?
If you have a positive test result, it is likely
you have COVID-19. There is a small chance
the test can give an incorrect positive result
(a false positive result). If you contact your
healthcare provider, your healthcare provider
will work with you to determine how best to care for you
based on your test result along with your medical history
and your symptoms.
WHAT SHOULD I DO NEXT?
Please consult your healthcare provider to discuss your
positive test result. You should self-isolate at home per CDC
recommendations to stop spreading the virus to others.
Please consult the CDC recommendations regarding self-
isolation at www.cdc.gov/coronavirus
WHAT DOES AN INVALID RESULT MEAN?
Your test has experienced an error. The
Scanwell Health App will guide you through
the next steps. The most common reasons
for an invalid result are not collecting
enough sample from your nose, applying
too little liquid to the test stick or applying the sample to
the wrong area of the test stick.
WHAT SHOULD I DO NEXT?
If you develop COVID-19 symptoms or your symptoms
become severe, seek medical attention immediately.
The Scanwell Health App will display the test result on your smartphone screen and provide further directions. A record of your test result and detailed information will remain
accessible in the Scanwell Health App. You should share your results with your healthcare provider.
WHAT DOES IT MEAN IF I HAVE A NEGATIVE
TEST RESULT?
A negative test result means that proteins from
the virus that causes COVID-19 were not found
in your sample. It is possible for the test to give
an incorrect negative result (false negative result)
in some people with COVID-19. This means you
could possibly still have COVID-19 even though
the test is negative. If your test result is negative,
and if you contact your healthcare provider for any reason,
your healthcare provider will consider the test result together
with all other aspects of your medical history (such as symptoms,
possible exposures, and places you have recently traveled) in
deciding how to care for you. The amount of antigen in a sample
may decrease the longer you have symptoms of infection. It is
important that you work with your healthcare provider to help
you understand the next steps you should take.
WHAT SHOULD I DO NEXT?
If you develop COVID-19 symptoms or your symptoms become
severe, seek medical attention immediately. If this is the first
test in a serial testing program, a second test must be done
between 24 and 48 hours after the first test.
What Do My Results Mean?
6
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www.bd.com/symbols-glossary
BD, the BD Logo and Veritor are trademarks of Becton,
Dickinson and Company or its affiliates. All other
trademarks are the property of their respective owners.
© 2021 BD. All rights reserved
• Dispose of the used test in the household trash. Do not
flush or pour test liquids down a drain.
• Store between 35°F - 86°F (2°C - 30°C) until use.
Becton, Dickinson and Company
7 Loveton Circle
Sparks, Maryland 21152 USA
256094
500054437(01)
2021-05
bd.com/e-labeling
Disposal & Storage
Support
Manufacturing Information
Limitations7
• Children, ages 2-13 years, must be tested by an
adult (18+ years old). The test has only been tested
in children age 2 and above.
• Do not use the test on children under 2 years of age.
• False negative results are possible, especially if you
have symptoms or recently had significant close
contact with a person with COVID-19.
• False positive results are possible, especially if you do
not have any symptoms.
• The test performance has only been assessed for use
with human nasal swabs.
• Positive test results do not rule out the possibility of
other infections.
For questions, or to report a problem, please call
1-844-4-VERITOR (844-483-7486) or visit
www.bdveritorathome.com. Additional information
is also available for you and your healthcare provider
at www.bdveritorathome.com. This Product Information
Leaflet, Quick Start Guide, and Fact Sheet for Individuals
are also available at www.bd.com/e-labeling.