CDRH COVID-19: Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing Templates - Appendix M - Fact Sheet for Patients (Template)

You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the [DEVICE/TEST NAME].

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

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.

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 infected 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/symptoms-testing/symptoms.html.

What is the [DEVICE/TEST NAME]?

The test is designed to detect the virus that causes COVID-19 in anterior nasal 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:

• You are being tested at regular intervals (serial testing) even though you do not have symptoms or risk factors for COVID-19; or

• You live in or have recently traveled to a place where transmission of COVID-19 is known to occur; or

• You have been in close contact with an individual suspected of or confirmed to have COVID-19; or

• You and your healthcare provider believe there is another reason to investigate your COVID-19 status.

Testing of the samples will help find out if you may have COVID-19.

[INCLUDE THIS TEXT IF YOUR INDICATION INCLUDES POOLING: Laboratories may use pooling when testing your specimen, which means they combine your sample with other individuals’ samples prior to testing and test them as a “pool”. The laboratory may return a result for the entire pool together or may return individual results.]

What are the known and potential risks and benefits of the test?

Potential risks include:

• Possible discomfort or other complications that can happen during sample collection.

• Possible incorrect test result (see below for more information).

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 those you come in contact with.

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.

[INCLUDE THIS TEXT IF YOUR INDICATION INCLUDES POOLING: If you were tested as part of a pool that returned a positive or invalid test result, you may have COVID-19 and should consider yourself to have a positive test result unless or until you receive a negative test result when re-tested individually. However, as most individuals in a positive pool will likely receive a negative result when re-tested individually, you should isolate until receiving a negative result when re-tested individually and should not be grouped with other individuals who have received a positive or presumptive positive result.]

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 infection. 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.

In particular, people infected with COVID-19 but who have no symptoms may not shed enough virus to trigger a positive test. This means that you could possibly still have COVID-19 even though the test result 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.

[INCLUDE THIS TEXT IF YOUR INDICATION INCLUDES POOLING: If your test result indicates your specimen was pooled and you have a negative test result there a small chance that your result is incorrect. You should talk with your healthcare provider if you are concerned.]

If you develop symptoms or your symptoms get worse, you should seek medical care. If you have the following symptoms you should seek immediate medical care at the closest emergency room:

- Trouble breathing

- Persistent pain or pressure in the chest

- New confusion

- Inability to wake up or stay awake

- Bluish lips or face

If you have no symptoms but have been tested because your healthcare provider thought you may have been exposed to COVID-19, you should continue to monitor your health and let your healthcare provider know if you develop any symptoms of COVID-19. If you develop symptoms you may need another test to determine if you have contracted the virus causing COVID-19.

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 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).

This test is authorized under the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing [include link to this letter] for use in [the specific laboratory, that is certified under CLIA and meets requirements to perform high complexity tests, in which it was developed] for [insert indication(s) from applicable appendix(ces)] using the test procedures validated in accordance with the requirements of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.

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 here:https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-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-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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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.