COVID-19 Antibody Testing
FAQs
This test is designed to detect antibodies in a blood sample that could give an indication that a patient had contracted COVID-19 at some point previously and had produced these antibodies to fight it.
Antibody testing does come with a few minor risks, primarily due to possible discomfort or complications during the sample collection process (blood draw). It is also possible to receive a false positive test or a false negative test, given the complexity of the virus and its close relationship to other coronavirus strands.
A positive test result could indicate that COVID-19 IgG antibodies are present in a patient’s blood, which might mean they have contracted the virus at some point and developed a natural antibody response to it. As the test name indicates, SARS-CoV-2 IgG, is focused on detecting IgG antibodies which remain in the blood after an infection has passed and indicate you may have developed antibodies that could protect you from future infection. Our test does not identify possible IgM antibodies, which are usually the initial antibodies produced by the immune system and often indicate more recent or active infection. Upon receiving a positive result, your healthcare provider will be able to work with you and determine the best course of care or treatment based on medical history or any prior symptoms. As mentioned previously, given the complexity of COVID-19 and the close relationship it shares with other strands of coronavirus, there is a chance you can have a false positive result.
A negative test results means that no antibodies were detected in your sample. If you do not have antibodies in your system, it likely indicates that you have not contracted the virus up to that point and it’s best to work with your healthcare provider to determine any next steps that are recommended. Again, it’s important to know that it’s possible to receive a false negative result and this can occur for a variety of reasons. A negative result may occur if you happen to be tested very recently after contracting the virus because your body may not have had time to produce antibodies for the infection, and therefore, they would not show on a possible test.
The FDA has made certain tests available through the Emergency Use Authorization, after having met certain criteria. The EUA for this test is supported by the Secretary of Health and Human Service’s declaration that the current circumstance justifies emergency use to help in the fight against COVID-19.
Sources:
Letter of authorization: https://www.fda.gov/media/137384/download
For Healthcare Providers: https://www.fda.gov/media/137381/download
For Patients: https://www.fda.gov/media/137382/download
Information for Use: https://www.fda.gov/media/137383/download

