Factsheet ­– Understanding Your COVID-19 Test Results

What is COVID-19?

Coronavirus Disease 2019 (COVID-19) is a respiratory illness caused by a virus. The virus is a new coronavirus with the official name SARS-CoV-2. This virus was first detected in Wuhan, China in December 2019.The virus has caused a global pandemic by spreading easily from person to person. SARS-CoV-2, is closely related to the virus that caused Severe Acute Respiratory Syndrome in 2003. It is a distant relative of four common coronaviruses that cause the common cold and have infected humans for hundreds to thousands of years. For additional information see the U.S. Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/index.html.

Why is the University of Maryland doing COVID-19 tests?

Researchers at the University of Maryland School of Public Health are doing tests to find out how COVID-19 spreads and whether masks help. We also want to help to produce new treatments. We will collect saliva or nasal swabs from healthy volunteers. We will use saliva and swabs from healthy people to detect infection before symptoms start. We will also collect saliva, swabs, and exhaled breath from volunteers who have mild cases of COVID-19. Testing samples from people with COVID-19 will help us learn about how the infection spreads. We will collect breath samples while the volunteers wear a face mask and after they take the mask off. We will do tests with and without face masks to find out how much masks can help stop spread of the virus. We will collect blood samples to learn how the body reacts to infection and to help develop new treatments.

What tests are being used at the University of Maryland to detect COVID-19?

We are using two types of tests for the coronavirus that causes COVID-19. One type is a research test and the other type is a clinical test. Most of our tests are research tests done in our research laboratory at the School of Public Health. We also have a rapid clinical test for nasal swabs that we can do in our School of Public Health (SPH) Clinic.

What are the research tests?

The research tests are complex tests which tell if the coronavirus is in a sample. They also measure how many viruses are in the sample. The testing will be done in our research lab using commercially available COVID-19 test kits. Although the kits we use are the same as those being used in certified clinical labs, we are not certified to do the tests for medical diagnosis. We are using research laboratory tests for testing saliva, nasal swabs, mobile phone swabs and exhaled breath.

Research test results cannot be used to diagnose you or make medical decisions because our research lab is not a certified clinical laboratory. Only certified clinical laboratories can do complex tests for medical diagnosis and treatment decisions. Although our research lab cannot do tests to diagnose you, our clinic can do a simple clinical test that can be used for medical diagnosis and treatment decisions. That test is described on the next page.

Why will my sample be tested using research methods?

We are using research methods because complex tests are needed to answer research questions. We are not certified to do complex tests for diagnosis. We are using research methods to test exhaled breath because there are no FDA-approved tests for virus in breath.

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

Benefits: Your results may give you early warning that you need to have a clinical test for COVID-19. The test results could also help public health officials identify and limit the spread of this virus. These results may help scientists identify how the virus spreads.

Risks: You may be a little uncomfortable when we swab your nose or you may have trouble producing saliva to put in the test tube. The research tests can’t tell you for sure if you have the virus. You may be anxious about the results of your test.

What is the clinical test?

Our SPH clinic is certified to use a simple, rapid clinical test for COVID-19. The test takes about 15 minutes and can diagnose whether you are infected with the coronavirus that causes COVID-19. We may not always be able to get supplies to do this test. When we can, we will use the clinic test:

• if you enroll for follow-up because of close contact with a person who is infected.

• if your weekly saliva research test is positive and you volunteer for more testing.

We will give you a report with the results of the rapid test that you can take to your medical provider. The results of the clinical test can be used for diagnosis and treatment decisions.

If my test is positive, does it mean that I have COVID-19?

If you test positive, it is likely that you have COVID-19. There is a chance the test can give a positive result that is wrong (false positive). If you test positive with the research test, we will ask you to get follow-up with a clinical test. We can do a rapid clinical test at the SPH clinic to confirm the results, when testing supplies are available.

We will immediately notify the University Health Center and/or State and County Health Departments of our results. They will decide if they want to do additional testing. We will ask you to self-isolate and take precautions not to spread the infection to others. We also recommend that you contact your personal medical care provider and inform them of the results of this research test.

Please see the CDC guidance on preventing spread of COVID-19 in homes and communities: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/protect-your-home.html

If my test is negative, does it mean that I do not have COVID-19?

If you have a negative test, it is still possible you have COVID-19. Testing a person can happen too early or too late to detect infection. There is also a chance that the test is wrong (false negative), meaning that you could still have COVID-19 even though the test results are negative.

What if my rapid clinical test is negative but my research test is positive?

If this happens, you need to be tested again. The research test can be more sensitive than the rapid clinical test. We can collect a nasal swab and send it to a certified clinical lab for you at no cost, or you can go elsewhere to be retested.

If you have had contact with a known case, regardless of the test result, you should continue to observe your health. You should do this for the full period of time recommended by CDC (currently 14 days) since the last time you were possibly exposed. You should also limit contact with others to keep from infecting them. You should limit your contact with others until 14 days since the last time you were exposed. Please see the CDC guidance on preventing spread of SARS-CoV-2 by self-quarantine: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html

What if I develop symptoms and fever?

If you get a fever or develop a cough or difficulty breathing during the14 days after possible exposure to a known case, avoid contact with others. Call your doctor or healthcare provider to tell them about your symptoms and your recent exposure for advice on whether you need to be seen in a medical facility. If you are having trouble breathing, call 9-1-1.

For more information see these websites:

https://coronavirus.maryland.gov/

https://www.cdc.gov/coronavirus/2019-ncov/index.html

https://umd.edu/4Maryland