COVID 19 antibody testing.
Santa Barbara Doctors Laboratory is pleased to announce the addition of the Autobio Anti-SARS-CoV-2 Rapid Test to our repertoire. Our test kits been authorized by the FDA under an EUA (Emergency Use Authorization). https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance.
These test kits have demonstrated a sensitivity and specificity of 99% to IgG antibodies against SARS-CoV-2 when blood samples were obtained at least 15 days after infection.
What is the Anti-SARS-CoV-2 Rapid Test?
The test is designed to detect antibodies to the virus that causes COVID-19 in blood specimens. According to a study recently published in JAMA the antibody response begins generally 1-2 weeks after symptom onset, with IgM antibodies (early antibodies) forming first and quickly disappearing and IgG antibodies (late antibodies) starting a bit later and persisting.
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?
The test can yield several possible results. Depending on the result, it may be more likely that you have COVID-19 and that you may need isolation to avoid the spread of the virus to others. Other results may indicate that you were previously infected. 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, and 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). In order to reduce the risk of false positive test results our laboratory will be sending positive test results to an outside laboratory for confirmatory testing, thus increasing the specificity of your result to 100%.
Does the presence of antibodies mean that I cannot get COVID-19 again?
No, there is currently no evidence to suggest that people who recover from COVID-19 and have antibodies are protected against reinfection with the illness. Because this is such a new virus, we haven’t had time to study whether or not antibodies offer protection from reinfection. We do, however, have data to support this concept with many other viruses including SARS-CoV-1.
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 during the early stages of your illness where your body hasn’t had time to produce antibodies to the 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. There are no COVID-19 antibody tests 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.