CDRH COVID-19: Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 Templates - Appendix J - Sample Updated Fact Sheet for Health Care Providers

FACT SHEET FOR HEALTHCARE PROVIDERS
COMPANY/LAB NAME
DEVICE/TEST NAME

Month DD, YYYY

This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the
DEVICE/TEST NAME.
The DEVICE/TEST NAME is authorized for use with
specific respiratory (and/or salvia) specimens collected
from individuals consistent with the Emergency Use
Authorization (EUA).

All patients whose specimens are tested with this
assay will receive the Fact Sheet for Patients:
COMPANY/LAB NAME - DEVICE/TEST NAME.
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
infection 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
Healthcare Professionals (see links provided in “Where
can I go for updates and more information?” section).

Coronavirus
Disease 2019
(COVID-19)

This test is to be performed only using specific
respiratory (and/or salvia) specimens collected
from individuals consistent with the Emergency
Use Authorization (EUA).








The DEVICE/TEST NAME can be used to test LIST
ALL SPECIMEN TYPES CLAIMED.
The DEVICE/TEST NAME should be ordered for the
detection of COVID-19 in individuals who
INDICATION STATEMENT.
THIS IS EXAMPLE BULLET FOR TESTS THAT
ARE AUTHORIZED WITH HOME COLLECTION
KITS: The DEVICE/TEST NAME can be used to test
individual nasal swab specimens that are selfcollected at home or in a healthcare setting by
individuals using an authorized home-collection kit
when determined to be appropriate by a healthcare
provider.
INCLUDE YOUR SAMPLE POOLING INDICATION
HERE: The DEVICE/TEST NAME can also be used
to test up to [INCLUDE INDICATION BASED ON
THE EXHIBIT YOU ARE CLAIMING].
The DEVICE/TEST NAME is authorized for use in
laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet requirements to perform
[high / high or moderate / high, moderate or waived]
complexity tests.

Specimens should be collected with appropriate infection
control precautions. Current guidance is 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 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

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
COMPANY/LAB NAME
DEVICE/TEST NAME
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
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.
The DEVICE/TEST NAME 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, delayed
diagnosis and treatment for the true infection causing the
symptoms, unnecessary prescription of a treatment or
therapy, or other unintended adverse effects.
Individuals included in a pool that returns a positive or
invalid result should be treated as a presumptive positive
unless or until they receive a negative result when retested individually. However, as most individuals in a
positive pool will likely receive a negative result when retested individually, they should isolate until receiving a
negative result when re-tested individually and should
not be cohorted with other individuals who have
received a positive or presumptive positive result.
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?

Month DD, YYYY

Coronavirus
Disease 2019
(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
COVID-19 infection to make an accurate diagnosis via
DEVICE/TEST NAME.
In addition, asymptomatic people infected with COVID19 may not shed enough virus to reach the limit of
detection of the test, giving a false negative result. In the
absence of symptoms, it is difficult to determine if
asymptomatic people have been tested too late or too
early. Therefore, negative results in asymptomatic
individuals may include individuals who were tested too
early and may become positive later, individuals who
were tested too late and may have serological evidence
of infection, or individuals who were never infected.
Specimens with low viral loads may not be detected in
sample pools due to the decreased sensitivity or
increased interference of pooled testing. Your
interpretation of negative results should take into
account clinical and epidemiological risk factors.
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 COVID19 is likely, and diagnostic tests for other causes of
illness (e.g., other respiratory illness) are negative.
If COVID-19 is suspected based on exposure history
together with other clinical findings, re-testing using a
new sample with a sensitive method or without pooling
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.
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

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
COMPANY/LAB NAME
DEVICE/TEST NAME
other close contacts for symptoms resulting in increased
risk of spread of COVID-19 within the community, or
other unintended adverse events.
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.

Month DD, YYYY

Coronavirus
Disease 2019
(COVID-19)

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.

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.
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,

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
3|Page

FACT SHEET FOR HEALTHCARE PROVIDERS
COMPANY/LAB NAME
DEVICE/TEST NAME

Month DD, YYYY

Coronavirus
Disease 2019
(COVID-19)

Where can I go for updates and more
information?
CDC webpages:
General: https://www.cdc.gov/COVID19
Symptoms:
https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html
Healthcare Professionals:
https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories:
https://www.cdc.gov/coronavirus/2019-nCoV/guidancelaboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings:
https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019ncov/infection-control/index.html

FDA webpages:
General: www.fda.gov/novelcoronavirus
EUAs:(includes links to patient fact sheet and manufacturer’s
instructions) https://www.fda.gov/medical-devices/coronavirusdisease-2019-covid-19-emergency-use-authorizations-medicaldevices/vitro-diagnostics-euas

COMPANY/LAB NAME:
COMPANY/LAB NAME
ADDRESS LINE 1
ADDRESS LINE 2
Customer Support:
+1 800 XXX-XXXX
customersupportemail@company.com
Technical Support:
+1 800 XXX-XXXX
techsupportemail@company.com

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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