302-3801 Sars-Cov-2 Patient Fact Sheet

FACT SHEET FOR PATIENTS Coronavirus
Disease 2019
Xpert® Xpress SARS-CoV-2– Cepheid March 20, 2020 (COVID-19)
You are being given this Fact Sheet because your Why was my sample tested?
sample(s) was tested for the Coronavirus Disease 2019 You were tested because your healthcare provider
(COVID-19) using the Xpert Xpress SARS-CoV-2 test. believes you may have been exposed to the virus that
causes COVID-19 based on your signs and symptoms
This Fact Sheet contains information to help you (e.g., fever, cough, difficulty breathing), and/or because:
understand the risks and benefits of using this test for
the diagnosis of COVID-19. After reading this Fact • You live in or have recently traveled to a place
Sheet, if you have questions or would like to discuss the where transmission of COVID-19 is known to occur,
information provided, please talk to your healthcare and/or
provider. • You have been in close contact with an individual
suspected of or confirmed to have COVID-19.
Testing of the samples will help find out if you may have
• For the most up to date information on COVID- COVID-19.
19 please visit the CDC Coronavirus Disease
What are the known and potential risks and benefits
2019 (COVID-19) webpage: of the test?
• https://www.cdc.gov/COVID19 Potential risks include:
• Possible discomfort or other complications that can

happen during sample collection.
What is COVID-19?
• Possible incorrect test result (see below for more
COVID-19 is caused by the SARS-CoV-2 virus. The
information).
virus, which can cause mild to severe respiratory illness,
was first identified in Wuhan, China, and has now spread
Potential benefits include:
globally, including the United States. There is limited
information available to characterize the spectrum of
• The results, along with other information, can help
clinical illness associated with COVID-19 but it likely
your healthcare provider make informed
spreads to others when a person shows signs or
recommendations about your care.
symptoms of being sick (e.g., fever, coughing, difficulty
breathing, etc.). • The results of this test may help limit the spread of
COVID-19 to your family and others in your
What is the Xpert Xpress SARS-CoV-2 test? community.
The test is designed to detect the virus that causes
COVID-19 in respiratory specimens, for example nasal What does it mean if I have a positive test result?
or oral swabs. If you have a positive test result, it is very likely that you
have COVID-19. Therefore, it is also likely that you may
be placed in isolation to avoid spreading the virus to
others. There is a very small chance that this test can
• 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.
1
P/N 302-3801, Rev A March 2020

FACT SHEET FOR PATIENTS Coronavirus
Disease 2019
Xpert® Xpress SARS-CoV-2– Cepheid March 20, 2020 (COVID-19)
give a positive result that is wrong (a false positive justifying emergency of IVDs, unless it is terminated or
result). Your healthcare provider will work with you to revoked by FDA (after which the test may no longer be
determine how best to care for you based on the test used).
results along with medical history, and your symptoms.
What does it mean if I have a negative test result?

A negative test result means that the virus that causes
COVID-19 was not found in your sample. For COVID-19,
a negative test result for a sample collected while a
person has symptoms usually means that COVID-19 did
not cause your recent illness.
However, it is possible for this test to give a negative

result that is incorrect (false negative) in some people
with COVID-19. This means that you could possibly still
have COVID-19 even though the test is negative. If this
is the case, your healthcare provider will consider the
test result together with all other aspects of your medical
history (such as symptoms, possible exposures, and
geographical location of places you have recently
traveled) in deciding how to care for you.
It is important that you work with your healthcare

provider to help you understand the next steps you
should take.
Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the
United States FDA. When there are no FDA-approved or
cleared tests available, and other criteria are met, FDA
can make tests available under an emergency access
mechanism called an Emergency Use Authorization
(EUA). 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
• 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.
2

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FACT SHEET FOR PATIENTS Coronavirus

• https://www.cdc.gov/COVID19 Potential risks include:

• Possible discomfort or other complications that can

P/N 302-3801, Rev A March 2020

What does it mean if I have a negative test result?

However, it is possible for this test to give a negative

It is important that you work with your healthcare

Is this test FDA-approved or cleared?

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