STAFF REPORT – The Boca Grande Health Clinic is pleased to announce a COVID-19 antibody test offered through Quest Diagnostics. The test is performed by blood draw. It is an ELISA test (an enzyme-linked immunosorbent assay, also called ELISA or EIA, is a test that detects and measures antibodies in your blood) for SARS-CoV2 IgG, the memory antibody for the virus that causes COVID-19. The test was developed by Abbott Laboratories.
This test gives positive or negative results of the presence of IgG (memory) antibodies in the blood. A positive result suggests possible previous exposure, possible currently resolving or possible previous infection with the virus that causes the COVID-19 illness. Of note, having these memory antibodies is not known to provide immunity to future infections of COVID 19 at this time.
The test results will be helpful to define the extent of any COVID-19 infections in our community which will help to guide recommendations regarding ongoing precautions for prevention of COVID-19.
Per Quest requirements to have the laboratory test drawn, you must not be currently ill and be asymptomatic from any recent illness for at least 10 days. At the time of the test you will be required to have your temperature taken and wear face covering. Helpful information on patient testing may be found at Patient information Abbott SARS CoV2 IgG test.
This service is covered by Medicare and most insurances. An initial telehealth visit with one of the Clinic physicians will be scheduled to go through screening questions regarding the specifics of any recent illness, travel history, medical history, etc. The limitations of the test results will be discussed with you and if you wish to have the test drawn, a laboratory appointment will be scheduled for you either at the Clinic or at Quest Diagnostics. Once the results are available, a second telehealth visit will be scheduled with one of the Clinic physicians to review and discuss your test results, answer any questions you may have and provide further any recommendations.
Potential risks associated with the test include the normal potential discomfort that can occur while having blood taken, and possible incorrect test results.
If you have a positive test result, it is likely that you have or previously had COVID-19, 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, including any previous symptoms, possible exposure to COVID-19 and the location of places you have recently traveled.
There is also the chance that this test can give a positive result that is wrong (a false positive 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 infection. 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.
If this is the case, your healthcare provider will consider the test result together with all other aspects of yourmedical history (such as symptoms, possible exposures, and geographical location of places you have recentlytraveled) 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, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization. The EUA for this test is supported by the Secretary of Health and Human Service’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).
If you are interested in having testing performed, contact the Clinic at their designated COVID-19 testing line, 964-0490, or email email@example.com. Include your contact information in the email.
The Clinic will continue to monitor this fast evolving pandemic and will keep you informed with the latest U.S. Centers for Disease Control (CDC) and state recommendations and updates. Helpful links are listed on their website at bghc.org.