Product Manual

At-Home COVID-19 Test
In the USA:
• This product has not been FDA cleared or approved but has
been authorized by FDA under an Emergency Use Authorization
(EUA).
• This product has been authorized only for the detection
of proteins from SARS- CoV-2, not for any other viruses or
pathogens.
• This product 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.
• For more information on EUAs visit: https://www.fda.gov/
emergency-preparednessand-response/mcm-legal-regulatory-
and-policy-framework/emergency-use-authorization
• For the most up to date information on COVID-19, please visit:
www.cdc.gov/COVID19
This document provides you with more information about this test.
Please READ this information completely before starting the test.
The Quick Start Guide presents steps required to download the
Scanwell Health App, create a Scanwell account and get started.
When performing the test, follow the step-by-step instructions
presented in the Scanwell Health App.
The following are required to perform the test but are
not included in the test kit:
• A compatible smartphone – For a full list of compatible
smartphones visit: www.bdveritorathome.com/devices
• Scanwell Health App – Download the free app from
your smartphone.
Do not begin if you do not have at least 20 minutes
available to focus on performing the test. Wash and dry
your hands before you begin. Perform the test indoors,
at room temperature (59°F - 86°F/15°C - 30°C) on
a clean, flat surface away from fans or open windows.
Perform the test in a brightly lit area, but away from
direct sunlight. Ensure a light source is in front of you,
and not directly overhead. Make sure your smartphone
is not in silent mode and is charged or charging. Turn
the phone’s volume up so you can hear the app alerts/
timers. Ensure your smartphone is not in a protective
case, the camera lens is clean and free of dirt and that
you have a cellular or Wi-Fi connection.
PRODUCT INFORMATION LEAFLET
For In Vitro Diagnostic (IVD) Use
• 1 kit box with tube holder
• 1 tube (with liquid) in foil pouch
• 1 nasal swab
• 1 test stick
• 1 scan card
• Quick Start Guide
• Fact Sheet for Individuals
• Product Information Leaflet (this document)
DO NOT OPEN KIT COMPONENTS UNTIL INSTRUCTED BY THE APP
KIT
BOX
TUBE
HOLDER
SWAB
TEST
STICK
SCAN
CARD
TUBE
CONTAINS
LIQUID
Kit Contents1
Intended Use2
The BD Veritor™ At-Home COVID-19 Test is a
chromatographic, digital immunoassay interpreted by
a compatible smartphone intended for the qualitative
detection of SARS-CoV-2 nucleocapsid antigens in direct
anterior nasal (nares) swab samples taken from individuals
with symptoms of COVID-19 or for use in individuals
without symptoms or other epidemiological reasons to
suspect COVID-19 when tested twice over two or three
days with at least 24 hours, and no more than 48 hours,
between tests. This test is authorized for non-prescription,
home use with anterior nasal swab samples self-collected
by individuals aged 14 years or older, or with adult
collected anterior nasal swab samples from individuals
aged two years or older.
The BD Veritor™ At-Home COVID-19 Test does not
dierentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2
nucleocapsid protein antigen. Antigen is generally
detectable in anterior nasal (nares) swabs during the acute
phase of infection. Positive results indicate the presence
of viral antigens, but clinical correlation with patient
history and other diagnostic information is necessary to
determine infection status. Positive results do not rule out
bacterial infection or co-infection with other viruses.
The agent detected may not be the definite cause of
disease. Individuals who test positive with the BD Veritor™
At-Home COVID-19 Test should self-isolate and seek
follow-up care with their physician or healthcare provider
as additional testing may be necessary.
Negative results should be treated as presumptive,
do not rule out SARS-CoV-2 infection and should not
be used as the sole basis for treatment or patient
management decisions, including infection control
decisions. Negative results should be considered in the
context of an individual’s recent exposures, history and
the presence of clinical signs and symptoms consistent
with COVID-19 and confirmed with a molecular assay,
if necessary, for patient management.
For serial testing programs, additional confirmatory
testing with a molecular test for negative results may be
necessary, if there is a high likelihood of COVID-19, such
as, an individual with a close contact with COVID-19 or
with suspected exposure to COVID-19 or in communities
with high prevalence of infection. Additional confirmatory
testing with a molecular test for positive results may also
be necessary if there is a low likelihood of COVID-19 such
Chemical name/CAS GHS code Concentration
Sodium Azide/26628-22-8
Acute Tox. 2 (Oral), H300
Acute Tox. 1 (Dermal), H310
0.095%
Triton X-100/9002-93 -1
Causes skin irritation (H315)
Causes serious eye irritation (H319)
2 %
WILL THIS TEST HURT?
No, the nasal swab may tickle but should not hurt.
You may experience watery eyes, feel some itchiness, or the
need to sneeze. If you feel pain or your nose starts to bleed,
remove the swab, and contact a medical professional.
WHAT ARE THE KNOWN RISKS & BENEFITS OF THIS TEST?
Potential risks include:
• Possible discomfort during sample collection.
• Possible incorrect test results (see Results section).
Potential benefits include:
• The results, along with other information, can
help your healthcare provider make informed
recommendations about your care.
• The results of this test may help limit the spread of
COVID-19 to your family and others in your community.
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 other day. By testing more frequently,
you may detect COVID-19 more quickly and reduce the
spread of infection.
WHAT DO I NEED TO KNOW ABOUT RESULTS FROM
SERIAL TESTING?
If your first or second test is positive, then proteins
from SARS-CoV-2 (the virus that causes COVID-19)
have been found in your specimen and you likely have
COVID-19. If you test positive with the BD Veritor™
At-Home COVID-19 Test, you should self-isolate and
seek follow-up care with your healthcare provider
to determine next steps. You may need additional
testing or treatment, depending on your personal
health history and other factors. If your first test
is negative, you should test again in 24-48 hours.
If both your first and second tests are negative,
you may not have COVID-19, however, you should
follow-up with your healthcare provider if you
are at high risk for COVID-19 infection or have
known contacts with COVID-19. Your healthcare
provider may suggest you need another test
to determine if you have contracted the virus
causing COVID-19.
as in individuals without known exposures to COVID-19 or
residing in communities with low prevalence of infection.
Individuals who test negative and continue to experience
COVID-like symptoms of fever, cough and/or shortness
of breath may still have SARS-CoV-2 infection and should
seek follow up care from their healthcare provider.
Individuals should provide all results obtained with
this product to their healthcare provider for public
health reporting. All healthcare providers will report all
test results they receive from individuals who use the
authorized product to relevant public health authorities
in accordance with local, state, and federal requirements
using appropriate LOINC and SNOMED codes, as defined
by the Laboratory In Vitro Diagnostics (LIVD) Test Code
Mapping for SARS-CoV-2 Tests provided by CDC.
The BD Veritor™ At-Home COVID-19 Test is intended
for non-prescription self-use and/or, as applicable for
an adult lay user testing another person aged 2 years
or older in a non-laboratory setting. BD Veritor™ At-Home
COVID-19 Test is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND
MOLECULAR TEST?
There are dierent 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 is highly 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 is appropriate, and when
you should discontinue self-isolation.
HOW ACCURATE IS THIS TEST?
Based on the results of a clinical study where the BD
Veritor™ At-Home COVID-19 Test was compared to
an FDA emergency use authorized high sensitivity
SARS-CoV-2 test, the BD Veritor™ At-Home COVID-19 Test
identified 81% of positive specimens and 100% of
negative specimens. The performance of this test is still
being studied in patients without signs and symptoms of
respiratory infection and for screening by serial testing.
Performance may differ in these populations. Based on
this information, negative results may require additional
testing to confirm your result. Please talk
to your healthcare provider to determine if you need
additional testing.
Hazardous Ingredients
Frequently Asked Questions
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