Reviewed and approved by Michael J. Bauer, MD

COVID-19 testing fact sheet

This fact sheet contains information to help you understand the risks and benefits of using the COVID-19 Molecular Laboratory Developed Test (LDT) provided by a Eurofins clinical laboratory. Eurofins clinical laboratories include the following: (i) Eurofins Viracor, Inc., (ii) Boston Heart Diagnostics Corporation, (iii) Diatherix Eurofins, LLC, (iv) EGL Genetic Diagnostics LLC, (v) Eurofins NTD Labs, LLC, (vi) Transplant Genomics, Inc., (vii) VRL Eurofins, and (viii) Eurofins Clinical Molecular Testing Services LLC. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider. It is important that if you are experiencing difficulty breathing and/or fever that you contact your healthcare provider as soon as possible.

MOLECULAR LABORATORY DEVELOPED TEST (LDT) COVID-19 AUTHORIZED TEST

The Molecular LDT COVID-19 Authorized Test has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal or oral swabs. Testing of your sample will help make the determination of whether you may have COVID-19.

The potential risks associated with the Molecular LDT COVID-19 Authorized Test include: (i) possible discomfort or other complications that can happen during sample collection; and (ii) possible incorrect test results (see below for more information). The potential benefits associated with the Molecular LDT COVID-19 Authorized Test include: (i) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results of this test may help limit the spread of COVID-19 to your family and others in your community.

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 give a positive result that is wrong (a false positive result). Contact your healthcare provider to determine how best to care for you based on the test results along with medical history, your symptoms, and other factors.

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, follow up with your healthcare provider to consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, geographical location of places you have recently traveled, and other factors) 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.

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, the 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 exit 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 emergency of IVDs, unless it is terminated or revoked by the FDA (after which the test may no longer be used).

DOWNLOADABLE COVID-19 FACT SHEETS

• For Healthcare Providers: EUA-LDT-SARS-CoV-2-PCR-HCP

• For Consumers: EUA-LDT-patientsx