Access Bio, Inc.

CareStart™ COVID-19 Antigen

 You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the CareStart™ COVID-19 Antigen test. 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 CareStart™ COVID-19 Antigen test? The CareStart™ COVID-19 Antigen is a type of test called an antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19 in nasopharyngeal swabs.

 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 others in your community

 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 because proteins from the virus that causes COVID-19 were found in your sample. 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. There is a very small chance 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 proteins from the virus that causes COVID-19 were 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. This means that you could possibly still have COVID- 19 even though the test is negative. If your test result 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. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay. It is important that you work with your healthcare provider to help you understand the next steps you should take.

 What are the differences between antigen tests and other COVID-19 tests? There are different kinds of tests for diagnosing COVID19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you do not have an additional test to determine if you are infected and may spread the infection to others, the CDC currently recommends that you should stay home until three things have happened:

-You have had no fever for at least 24 hours (that is one full days of no fever without the use of medicine that reduces fevers)


-Other symptoms have improved (for example, when your cough or shortness of breath has improved)


-At least 10 days have passed since your symptoms first appeared.

 For more information, the CDC has provided guidelines on how to prevent the spread of COVID-19 if you are sick: https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf

 Is this test FDA-approved or cleared? No. 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, 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 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 emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

 What are the approved alternatives? There are approved influenza tests, but there is not yet an approved available alternative test for influenza combined with COVID-19 in one test. 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

 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/concern.