CORONAVIRUS (COVID-19) VACCINE-GENERATED ANTIBODY TEST
IgM antibodies are the first type of antibody produced by the immune system. The IgM antibody is detected if you have an active infection or have recently been exposed to the virus. IgG antibodies can usually be detected 10 days from suspected infection or post symptom onset. The IgG antibodies will remain in the blood after an infection has passed.
Coronavirus (COVID-19) is an illness caused by a virus that is transmitted from person to person. Symptoms can range from mild (or no symptoms) to severe illness. One can be infected from respiratory droplets when an infected person sneezes or coughs. Other ways that one can be infected is by touching a surface or object that has the virus on it, and then touching their mouth, nose, or eyes.
This test will identify both IgM and IgG antibodies if present. The IgM antibody is detected if you have recently been exposed to the virus. The IgG antibody is detected if you were previously exposed to the virus.
This is not a diagnostic test for an active infection.
Free options for testing are available. The COVID-19 Antibody Test may be covered by your insurance plan or the government, with no out-of-pocket costs to you. If you are looking for that no-cost option, contact your healthcare provider.
You may be able to submit the expense associated with this test to your Health Savings Account, Flexible Spending Account, Health Reimbursement Account, or similar account for reimbursement. Please check with your health account administrator.
Note: This test can sometimes detect antibodies from other coronaviruses, which can cause a false positive result if you have been previously diagnosed with or exposed to other types of coronaviruses. Additionally, if you test too soon, your body may not have produced enough IgG antibodies to be detected by the test yet, which can lead to a false negative result.
Antibody blood tests, also called serologic tests, check your blood for antibodies that would show if you have had a previous infection. Antibodies are proteins that help fight off germs. A serologic test may not be able to show if you have a current infection, because it can take 1 to 3 weeks to make antibodies after symptoms occur.
We do not know yet if having antibodies to SARS-CoV-2 can protect someone from getting infected with that virus again, or how long that protection might last. Scientists are doing studies to answer those questions.
If you test positive or negative for COVID-19, no matter the type of test, you still should take preventive measures to protect yourself and others. *
If you believe you have been exposed to COVID-19 or have had symptoms in the past, you may be a good candidate for this test. You must be asymptomatic (free of symptoms) for at least seven (7) days prior to testing.
This test requires a simple finger stick.
No, fasting is not required. There are no dietary or medicinal restrictions to take this test.
Sethi labs ordering physician will provide the required physician’s order on your behalf.
Results from the COVID-19 IgG/IgM test are generally available within 15 minutes
You can share your results with your healthcare provider
Early after infection (usually after the first week), a class of antibodies known as immunoglobulin M (IgM) develop, although they typically do not last long. Later, after the first 2-4 weeks following infection, IgG, a more durable antibody, is produced.
Detection of microbe-specific IgM and IgG in circulating blood (a ‘serologic’ test) serves as a traditional method to determine whether a person has been infected with that pathogen, either recently (IgM) or more distantly (IgG).**
Antibody tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who have been exposed to the SARS-CoV-2 virus and may have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection. ****
No, but it has been granted FDA EUA authorization. During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available options.
According to the FDA “more flexibility was needed during a pandemic of this scale and speed, and incorporating feedback from the medical community, states and test developers, we have also provided regulatory flexibility for serological tests in an effort to provide laboratories and health care providers with early access to these tests with the understanding that the FDA had not reviewed or authorized (or “approved”) them, at least not initially, and these tests should not be used for diagnosing or excluding active SARS-CoV-2 infection. Specifically, last month, as part of our broader strategy, the FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: 1) the tests are validated by the developer to determine that they are accurate and reliable, 2) notification of the developer’s validation is provided to FDA, and 3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. “***
The test you receive follows the above-referenced FDA guidelines.
COVID-19 Antibody Testing should not be the sole determination for staffing. Since we do not know if COVID-19 antibodies protect someone from future infection, you cannot be assured that they will not get re-infected.
If you have a positive test result, it is likely that you may have had COVID-19 and might have developed an antibody response to the virus. There is a small 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. A negative result may occur if you are tested early in your illness and 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. ***
You can share your results with your healthcare provider.
Free options for testing are available. The COVID-19 Antibody Test may be covered by your insurance plan or the government, with no out-of-pocket costs to you. If you are interested in this option, please contact your healthcare provider. Sethi labs provide transparent pricing and an option for consumers who want fast and convenient access to laboratory testing. Please note that you can use your HSA or FSA for the cost of the test.