CDRH COVID-19: EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests Templates - Fact Sheet for Patients

FACT SHEET FOR PATIENTS
Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests
Updated: November 15, 2021

You are being given this Fact Sheet because your
sample(s) was tested for the Coronavirus Disease 2019
(COVID-19) using a Molecular Laboratory Developed
Test (LDT) COVID-19 Authorized Test (Molecular LDT
COVID-19 Authorized Test) that has been issued an
Emergency Use Authorization (EUA) by FDA.
This Fact Sheet contains information to help you
understand the risks and benefits of using this test for
the diagnosis of COVID-19. After reading this Fact
Sheet, if you have questions or would like to discuss the
information provided, please talk to your healthcare
provider.

For the most up to date information on COVID-19
please visit the CDC Coronavirus Disease 2019
(COVID-19) webpage:
https://www.cdc.gov/COVID19

Coronavirus
Disease 2019
(COVID-19)

What is the Laboratory Developed Test?
The Molecular LDT COVID-19 Authorized Test is
designed, for use in a single laboratory, to detect the
virus that causes COVID-19 in respiratory specimens,
for example nasal or oral swabs.
Why was my sample tested?
You were tested because your healthcare provider
believes you may have been exposed to the virus that
causes COVID-19 based on your signs and symptoms
(e.g., fever, cough, difficulty breathing), and/or because:
x
x

You live in or have recently traveled to a place
where transmission of COVID-19 is known to occur,
and/or
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
COVID-19.
What are the known and potential risks and benefits
of the test?

What is COVID-19?
COVID-19 is caused by the SARS-CoV-2 virus which is
a new virus in humans causing a contagious respiratory
illness. COVID-19 can present with a mild to severe
illness, although some people with COVID-19 may have
no symptoms at all. Older adults and people of any age
who have underlying medical conditions have a higher
risk of severe illness from COVID-19. Serious outcomes
of COVID-19 include hospitalization and death. The
SARS-CoV-2 virus can be spread to others not just while
one is sick, but even before a person shows signs or
symptoms of being sick (e.g., fever, coughing, difficulty
breathing, etc.). A full list of symptoms of COVID-19 can
be found at the following link:
https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html.

x

Potential risks include:
x
x

Possible discomfort or other complications that can
happen during sample collection.
Possible incorrect test result (see below for more
information).

Potential benefits include:
x
x

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.

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 PATIENTS
Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests
Updated: November 15, 2021

What does it mean if I have a positive test result?
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. You should follow CDC guidance to reduce the
potential transmission of disease. There is a smaller
possibility that this test can give a positive result that is
wrong (a false positive result) particularly when used in a
population without many cases of COVID-19. Your
healthcare provider will work with you to determine how
best to care for you based on the test 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.
However, it is possible for this test to give a negative
result that is incorrect (false negative) in some people
with COVID-19. You might test negative if the sample
was collected early during your infection. You could also
be exposed to COVID-19 after your sample was
collected and then have become infected.

Coronavirus
Disease 2019
(COVID-19)

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 diagnostics,
unless it is terminated or revoked by FDA (after which
the test may no longer be used).
What are the approved alternatives?
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
https://www.fda.gov/medical-devices/devicehere:
advice-comprehensive-regulatory-assistance/medicaldevice-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-andresponse/mcm-legal-regulatory-and-policyframework/emergency-use-authorization.

This means that you could possibly still have COVID-19
even though the test is negative. If your test is negative,
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. 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

x

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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