Coronavirus Disease 2019 (COVID-19)
You are being given this Fact Sheet because your sample(s) is being tested or was tested for antibodies to the virus that causes Coronavirus Disease 2019 (COVID-19) using the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This Fact Sheet contains information to help you understand the risks and benefits of using this test to evaluate your adaptive immune response to SARS-CoV-2, the virus that causes 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. The virus, which can cause mild to severe respiratory illness has now spread globally, including the United States. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, headache, sore throat or new loss of taste or smell.
How are people tested for COVID-19?
Two kinds of tests are currently available for COVID 19: diagnostic tests and antibody tests.
What is the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) test?
This test is an antibody test. It will help assess if you have antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.
What are the known and potential risks and benefits of the test?
Potential risks include:
Potential benefits include:
What does it mean if I have a positive test result?
If you have a positive test result, it is possible that you have had recent or prior COVID-19 infection and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, your symptoms, possible exposures, and geographic location of places you have recently traveled. There is also the small possibility that this test can give a positive result that is wrong (a false positive result). Even a high-performing antibody test when used in a population without many cases of COVID-19 infection may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Your healthcare provider will work with you to determine the likelihood of false result.
It is not known how long antibodies to SARS-CoV-2 will remain present in the body after infection. It is not known whether having antibodies to SARS-CoV-2 will protect you from getting infected again or help reduce the severity or duration of a future COVID-19 infection.
What does it mean if I have a negative test result?
A negative test result means that the antibodies to 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. A negative result may occur if you are tested early in your illness and your body hasn't had time to produce antibodies to infection. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, 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.
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. 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 available alternatives?
There are no approved available alternative tests. FDA has issued EUAs for other antibody tests that can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov.
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/coronavirus/2019-ncov.
In addition, please also contact your healthcare provider with any questions/concerns.