Product Manual

IMPORTANT DO’S AND DON’TS
DO:
Use the InteliSwab
TM
COVID-19 Rapid
Test for testing for COVID-19 infection.
Follow the Instructions for Use (reverse
side) to obtain accurate results. Inadequate
sampling may result in false results.
Inspect the divided pouch. If the divided
pouch has been damaged, discard the
divided pouch and its contents. The
results from the InteliSwab
TM
COVID-19
Rapid Test may not be valid if the
divided pouch is damaged.
Use adequate lighting to read a test result.
Use the test device and tube containing
fluid only once and dispose of both
properly.
Wash hands thoroughly prior to testing
and after use.
Report all test results (whether positive
or negative) to your healthcare provider.
Store the InteliSwab
TM
COVID-19 Rapid
Test in a dry location between 35°-86°F
(2°-30°C). Bring the divided pouch to
room temperature (within 59°-104°F,
15°-40°C) before opening.
Keep out of reach of children.
OraSure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015 USA
[phone]
www.OraSure.com
© 2021 OraSure Technologies, Inc.
3001-3570 rev. 06/21
IMPORTANT INFORMATION
ABOUT THE INTELISWAB
TM
COVID-19 RAPID TEST
For consumer over-the-counter use.
The InteliSwab
TM
COVID-19 Rapid Test is for
the detection of the antigen associated with
COVID-19, not for any other viruses or pathogens.
Invalid results can occur if the sample and
thereagents do not flow up the test device.
The presence of a line next to the “C” does not
indicate that an adequate sample was collected
during the swabbing of the nostrils.
The InteliSwab
TM
COVID-19 Rapid Test is for use
under Emergency Use Authorization (EUA) only.
This test has not been FDA cleared or approved.
This test has been authorized by FDA under EUA.
This product has been authorized only for the
detection of proteins from SARS-CoV-2, not for
any other viruses or pathogens.
The emergency use of this test is only
authorized for the duration of the declaration
that circumstances exist justifying the
authorization of emergency use of IVDs 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.
FREQUENTLY ASKED QUESTIONS
What is COVID-19? COVID-19
(coronavirus disease 2019) is a contagious
virus that may cause mild to severe
respiratory illness, aecting other organs
and systems potentially resulting in
hospitalization or death. The presence
of a specific antigen (the SARS-CoV-2
nucleocapsid protein antigen) indicates
that an individual is currently infected with
COVID-19 (even without the presence of
symptoms) and can transmit the virus.
What are common symptoms
of COVID-19? Symptoms of COVID-19
may appear 2-14 days after exposure and
may include fever, cough, shortness of breath,
fatigue, muscle or body aches, headache, loss
of taste or smell, sore throat, congestion, or a
runny nose, nausea or vomiting and diarrhea.
It is also possible for someone infected with
COVID-19 to have no symptoms.
What is the dierence between
a COVID-19 antigen, a molecular
and an antibody test, and what
kind of test is the InteliSwab
TM
COVID-19 Rapid Test? There are
dierent kinds of tests for diagnosing
COVID-19. The InteliSwab
TM
COVID-19
Rapid Test is an antigen test. Antigen
tests detect proteins, small parts, from
the SARS-CoV-2 virus. Antigen tests are
designed to detect virus levels that
reflect active infection. Molecular tests
(also known as PCR tests) detect genetic
material from the virus (RNA). Another
type of test is an antibody test. A COVID-19
antibody test detects antibodies that have
been made by your immune system in
response to a previous COVID-19 infection.
Antibody tests are not suitable to diagnose
an active COVID-19 infection.
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 are the known and potential
risks and benefits of thistest?
Potential risks include:
Possible discomfort during sample collection.
Possible incorrect results.
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.
How accurate is the InteliSwab
TM
COVID-19 Rapid Test? The InteliSwab™
COVID-19 Rapid Test is a lateral flow in vitro
diagnostic antigen test to detect
COVID-19. Antigen tests are designed
to detect active infection in individuals.
A clinical study was conducted during
February and April of 2021 to determine
the performance of the InteliSwab™
COVID-19 Rapid Test. A total of 146
individuals with signs and symptoms
of COVID-19 within the first 7 days of
symptom onset were enrolled across 5
dierent locations in the US. Subjects 18
years or older independently collected
the lower nasal sample and completed
the home use test. The InteliSwab™
COVID-19 Rapid Test results were compared
to highly sensitive molecular FDA Authorized
SARS-CoV-2 assays to determine test
performance. The InteliSwab™ COVID-19
Rapid Test correctly identified 84%
of the positive samples. Additionally,
the InteliSwab™ COVID-19 Rapid Test
correctly identified 98% of negative
samples.
What if you test positive?
A positive result means that it is
very likely you have COVID-19 and it
is important to report your results to
your healthcare provider.
You should isolate yourself at home
to avoid spreading the virus to others.
There is a very small chance that this test
can give a positive result that is wrong
(false positive).
Information about Emergency
Use Authorizations and
COVID-19? For more information
onEUAs go here: https://www.fda.gov/
emergency-preparedness-and-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.
Visit InteliSwab.com to obtain the
complete Instructions for Use and
FactSheets.
What if you test negative?
If you receive a second negative result
24 to 36 hours after your first negative
test, then you are likely not infected
withCOVID-19.
If you have symptoms, you may have
adierent virus or type of infection.
You may have COVID-19 and still get
anegative result (false negative) if:
You didn’t perform the test correctly,
such as not swabbing correctly or not
waiting 30 minutes for test results.
The level of antigen from the COVID-19
virus was below the test limits.
You have had signs and symptoms
ofCOVID-19 for more than 7 days.
This means you could still possibly
have COVID-19 even though the test
is negative. Please see your health care
provider. Your healthcare provider will
consider the test result along with all
other aspects of your medical history,
including your symptoms and possible
COVID-19 exposures to decide how to
care for you. It is important for you to
work with your healthcare provider to
help you understand the next steps
youshould take. A dierent type of
testmight be necessary to determine
whether or not you have COVID-19.
Why do I have a test line and
no control line? If you have a test line
and no control line, your test is positive.
When the level of virus in the sample is
high, the line next to the “C” may not be
present or may be very faint. The line
next to the “C” must be visible to read a
negative test result. Please see the other
side of this Instructions for Use and the
enclosed reference card to help you
understand how to interpret test results.
Will this test hurt? No. The nasal
swab is not sharp and it 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.
Is the solution in the tube
harmful? No. The solution in the tube
contains potentially harmful chemicals
(Triton X-100 and ProClin 950); however,
laboratory studies have shown them to
be nontoxic at the levels contained in the
solution. The developer solution should only
be used as directed; do not ingest; keep
out of the reach of children; avoid contact
with skin and eyes. If the solution contacts
the skin or eye, flush with copious amounts
of water. If irritation persists, seek medical
advice: https://www.poison.org/contact-us
or 1-800-222-1222.
MORE QUESTIONS ABOUT
THE INTELISWAB
TM
COVID-19
RAPID TEST?
If you have any questions about the
InteliSwab
TM
COVID-19 Rapid Test, please
contact our toll-free consumer helpline at
1-833-601-0127 or visit www.InteliSwab.com.
The InteliSwab™ COVID-19 Rapid Test
Letter of Authorization, authorized
Fact Sheets and authorized labeling are
available on the FDA website and
www.InteliSwab.com.
LEARN MORE:
DO NOT:
Use the InteliSwab
TM
COVID-19 Rapid
Test on children under the age of 15.
Anadult must perform this test on
children between the ages of 15 and 17.
Use the InteliSwab
TM
COVID-19 Rapid
Test beyond the expiration date.
Use if the packaging has been opened
or damaged.
Open the divided pouch until you
areready to start the test.
Reuse the test device or tube.
EXPLANATION OF SYMBOLS
SWAB
both nostrils
SWIRL
in the tube
SEE
your results
INTENDED USE
The InteliSwab COVID-19 Rapid Test is a single-
use lateral flow immunoassay with an integrated
swab, intended for the qualitative detection of the
nucleocapsid protein antigen from SARS-CoV-2
from individuals with or without symptoms or other
epidemiological reasons to suspect COVID-19 when
tested twice over two or three days with at least
24 hours but not more than 36 hours between
tests. This test is authorized for non-prescription
home use with self-collected anterior nasal samples
from individuals 18 years or older or adult collected
anterior nasal samples from individuals age 15 years
or older.
The InteliSwab COVID-19 Rapid Test does not
dierentiate between SARS-CoV-1 and SARS-CoV-2.
Results are for the identification of SARS-CoV-2
nucleocapsid protein antigen. Antigen is generally
detectable in anterior nasal samples during the
acute phase of infection. Positive results indicate
thepresence of viral antigens, but clinical correlation
with past medical 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 and
the agent detected may not be the definite cause
of disease. Individuals who test positive with the
InteliSwab COVID-19 Rapid 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
and confirmation with molecular assay, if necessary,
for patient management, may be performed.
Negative results do not rule out COVID-19 and
shouldnot be used as the sole basis for treatment
orpatient management decisions.
For serial testing programs, additional confirmatory
testing with a molecular test for negative results
may be necessary, if there is a high likelihood of
SARS-CoV-2 infection, 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SARS-CoV-2 infection, such 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-19 like symptoms of fever,
coughand/or shortness of breath may still have
SARS-CoV-2 infection and should seek follow up
care with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 HYPERLINK
"https://www.cdc.gov/csels/dls/sars-cov-2-livd-
codes.html" Laboratory In Vitro Diagnostics (LVID)
Test Code Mapping for SARS-CoV-2 Tests provided
by CDC.
The InteliSwab COVID-19 Rapid Test is intended
fornon-prescription self-use and/or as applicable
for anadult lay user testing another person 15
years of age or older in a non-laboratory setting.
The InteliSwab COVID-19 Rapid Test is only for
use underthe Food and Drug Administration’s
Emergency UseAuthorization.