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 Healthcare Pro

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

This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of 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.
The Molecular LDT COVID-19 Authorized Test is
authorized for use on respiratory specimens collected
from individuals suspected of COVID-19 by their
healthcare provider.

All patients whose specimens are tested with an
authorized test will receive the Fact Sheet for
Patients: Molecular Laboratory Developed Test
(LDT) COVID-19 Authorized Tests.

This test is to be performed only using
respiratory specimens collected from individuals
suspected of COVID-19 by their healthcare
provider.
Healthcare Professionals (see links provided in “Where
can I go for updates and more information?” section).




What are the symptoms of COVID-19?
Many patients with COVID-19 have developed fever
and/or symptoms of acute respiratory illness (e.g.,
cough, dyspnea), although some individuals experience
only mild symptoms or no symptoms at all. The current
information available to characterize the spectrum of
clinical illness associated with COVID-19 suggests that,
when present, symptoms include cough, shortness of
breath or dyspnea, fever, chills, myalgias, headache,
sore throat, new loss of taste or smell, nausea or
vomiting or diarrhea. Signs and symptoms may appear
any time from 2 to 14 days after exposure to the virus,
and the median time to symptom onset is approximately
5 days. For further information on the symptoms of
COVID-19 please see the link provided in “Where can I
go for updates and more information?” section.
Public health officials have identified cases of COVID-19
throughout the world, including the United States. Please
check the CDC COVID-19 webpage (see link provided in
“Where can I go for updates and more information?”
section at the end of this document) or your local
jurisdictions website for the most up to date information.
What do I need to know about COVID-19 testing?
Current information on COVID-19 for healthcare
providers is available at CDC’s webpage, Information for

Coronavirus
Disease 2019
(COVID-19)

The Molecular LDT COVID-19 Authorized Test can
be used to test respiratory specimens validated in
the laboratory that developed the test for COVID-19.
The Molecular LDT COVID-19 Authorized Test
should be ordered for the detection of nucleic acid
from SARS-CoV-2 in individuals suspected of
COVID-19 by their healthcare provider.
The Molecular LDT COVID-19 Authorized Test is
only authorized for use at the laboratory that
developed the test for COVID-19 that is certified
under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to
perform high complexity tests.

Specimens should be collected with appropriate infection
control precautions. Current guidance for COVID-19
infection control precautions are available at the CDC’s
website (see links provided in “Where can I go for
updates and more information?” section).
When collecting and handling specimens from
individuals suspected of being infected with the virus that
causes COVID-19, appropriate personal protective
equipment should be used as outlined in the CDC
Interim Laboratory Biosafety Guidelines for Handling and
Processing Specimens Associated with Coronavirus
Disease 2019 (COVID-19). For additional information,
refer to CDC Interim Guidelines for Collecting, Handling,
and Testing Clinical Specimens from Persons Under
Investigation (PUIs) for Coronavirus Disease 2019
(COVID-19) (see links provided in “Where can I go for
updates and more information?” section).
What does it mean if the specimen tests positive for
the virus that causes COVID-19?
A positive test result for COVID-19 indicates that RNA
from SARS-CoV-2 was detected, and therefore the

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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FACT SHEET FOR HEALTHCARE PROVIDERS
Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests
Updated: November 15, 2021

Coronavirus
Disease 2019
(COVID-19)

patient is infected with the virus and presumed to be
contagious. Laboratory test results should always be
considered in the context of clinical observations and
epidemiological data (such as local prevalence rates and
current outbreak/epicenter locations) in making a final
diagnosis and patient management decisions. Patient
management should be made by a healthcare provider
and follow current CDC guidelines.

19 is likely, and diagnostic tests for other causes of
illness (e.g., other respiratory illness) are negative. If
COVID-19 is still suspected based on exposure history
together with other clinical findings, re-testing with an
alternative method should be considered by healthcare
providers in consultation with public health authorities.
Additional testing may be helpful to ensure testing was
not conducted too early.

The Molecular LDT COVID-19 Authorized Test has been
designed to minimize the likelihood of false positive test
results. However, it is still possible that this test can give
a false positive result, even when used in locations
where the prevalence is below 5%. In the event of a
false positive result, risks to patients could include the
following: a recommendation for isolation of the patient,
monitoring of household or other close contacts for
symptoms, patient isolation that might limit contact with
family or friends and may increase contact with other
potentially COVID-19 patients, limits in the ability to
work, the delayed diagnosis and treatment for the true
infection causing the symptoms, unnecessary
prescription of a treatment or therapy, or other
unintended adverse effects.

Risks to a patient of a false negative test result include:
delayed or lack of supportive treatment, lack of
monitoring of infected individuals and their household or
other close contacts for symptoms resulting in increased
risk of spread of COVID-19 within the community, or
other unintended adverse events.

All laboratories using this test must follow the standard
testing and reporting guidelines according to their
appropriate public health authorities.
What does it mean if the specimen tests negative for
the virus that causes COVID-19?
A negative test result for this test means that SARSCoV-2 RNA was not present in the specimen above the
limit of detection. However, a negative result does not
rule out COVID-19 and should not be used as the sole
basis for treatment or patient management decisions. It
is possible to test a person too early or too late during
infection to make an accurate diagnosis via the
Molecular LDT COVID-19 Authorized Test.
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient’s recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should
especially be considered if the patient’s recent
exposures or clinical presentation indicate that COVID-

The performance of this test was established based on
the evaluation of a limited number of clinical specimens.
The clinical performance has not been established in all
circulating variants but is anticipated to be reflective of
the prevalent variants in circulation at the time and
location of the clinical evaluation. Performance at the
time of testing may vary depending on the variants
circulating, including newly emerging strains of
SARSCoV-2 and their prevalence, which change over
time.
What is an EUA?
The United States FDA has made this test available
under an emergency access mechanism called an
Emergency Use Authorization (EUA). The EUA 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 (IVDs)
for the detection and/or diagnosis of the virus that
causes COVID-19.
An IVD made available under an EUA has not
undergone the same type of review as an FDA-approved
or cleared IVD. FDA may issue an EUA when certain
criteria are met, which includes that there are no
adequate, approved, available alternatives, and based
on the totality of scientific evidence available, it is
reasonable to believe that this IVD may be effective in
diagnosing COVID-19.

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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FACT SHEET FOR HEALTHCARE PROVIDERS
Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests
Updated: November 15, 2021

The EUA for this test is in effect for the duration of the
COVID-19 declaration justifying emergency use of IVDs,
unless terminated or revoked (after which the test may
no longer be used).
What are the approved available 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
here: https://www.fda.gov/medical-devices/deviceadvice-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.

Coronavirus
Disease 2019
(COVID-19)

Where can I go for updates and more
information?
CDC webpages:
General: https://www.cdc.gov/coronavirus/2019-ncov/index.html
Symptoms:
https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html
Healthcare Professionals:
https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html
Information for Laboratories:
https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings:
https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019ncov/php/infection-control.html

FDA webpages:
General: www.fda.gov/novelcoronavirus
EUAs:(includes links to fact sheet for individuals and
manufacturer’s instructions) https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergency-useauthorizations-medical-devices/in-vitro-diagnostics-euas

LABORATORY CONTACT:
Contact information for the laboratory that developed the Molecular
LDT COVID-19 Authorized Test must be provided to the Healthcare
Provider in the test report or material/mechanism (e.g., email) that
accompanies this Fact Sheet and the test results.

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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