COVID-19 Antibody Indicator Test Scheduling


Information and Basic Education on Antibody Testing for SARS-COV-2 (COVID-19)

THIS INFORMATION IS INTENDED TO HELP YOU DECIDE IF ANTIBODY TESTING MAY BE RIGHT FOR YOU

YOU SHOULD ALSO DISCUSS THIS TEST WITH YOUR REGULAR HEALTHCARE PROVIDER

Common Questions
This antibody test...
  • determines the presence of COVID-19 antibodies, not the virus itself
  • is made in the United States by a FDA-regulated manufacturer
  • is a simple finger prick test, not a blood draw like some antibody tests
  • returns results within 15 minutes
  • like other widely available finger prick antibody tests, is not currently covered by insurance but if allowable in the future, will be billed to insurance accordingly
Additional information is listed below regarding antibodies and the role of antibody testing in COVID-19.
Q: What is SARS-COV-2?
Viruses are typically named based on their genetic structure in order to facilitate the development of diagnostic tests, vaccines and medicines. Viruses are named by the International Committee on Taxonomy of Viruses (ICTV). Diseases are named to enable clearer discussion on disease prevention, spread, transmissibility, severity and treatment. Human disease preparedness and response is, in part, the historic role of the World Health Organization (WHO) and diseases are officially named by the WHO in a system known as the International Classification of Diseases (ICD).
The International Committee on Taxonomy of Viruses announced “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” as the name of the new virus on February 11, 2020. This name was chosen because the virus is genetically related to the coronavirus responsible for the SARS outbreak of 2003. While related, the two viruses are different. Coronaviruses cause illnesses with severities ranging from the common cold to SARS. “Novel” is a word that means “new”. That is why initially some people referred to SARS-COV-2 as “novel coronavirus”.
“COVID-19” is an accepted term by the medical community and is derived by combining three words as follows: ‘CO' (corona) + 'VI' (virus) + 'D' (disease). Since the disease was diagnosed in 2019, ‘-19’ is added to the name.
Q: What is an Antibody?
An antibody, also called an immunoglobulin (abbreviated Ig), is a protective protein produced by the immune system in response to the presence of a foreign substance (called an antigen), such as a pathogen (e.g. virus or bacteria) or a toxin (e.g. bee sting, snake venom). Antibodies recognize and latch onto antigens in order to help remove them from the body. Antibodies are proteins produced and secreted by B cells (a type of lymphocyte which is a white blood cell).
The body makes many kinds of antibodies, but the two most relevant to this discussion are called IgM and IgG.
IgG is the most abundant antibody isotype in the blood (plasma), accounting for 70 to 75% of human immunoglobulins (antibodies). IgG binds antigen (e.g. bacteria, toxins, viruses, etc.) and drives the recognition of antigen-antibody complexes by specialized immune cells (e.g. white blood cells). IgG is largely responsible for long term immunity after infection or vaccination.
IgM usually circulates in the blood, accounting for about 10% of human immunoglobulins. IgM generally has a more complex structure in which five basic Y-shaped molecules are linked together. B cells generally produce IgM first in response to microbial infection/antigen invasion, so these antibodies are seen earlier in infections than IgG. These are early phase immunoglobulins that will develop first during acute infection.
When IgM antibodies are present, they can indicate that a patient has an active or recent infection with SARS-CoV-2. IgG antibodies develop later following infection, and generally do not begin to appear until 7 – 10 days after infection. When IgG antibodies are present it, often indicates a past infection but does not exclude recently infected patients who are still contagious, especially if detected along with IgM antibodies. It is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer true and complete immunity to infection.
An important feature is that each antibody recognizes a specific antigen, a phenomenon called "antibody specificity.” For example, an antibody that recognizes the mumps virus cannot recognize the measles virus and can only recognize one particular part (binding site) on the mumps virus. There will likely be multiple antibodies to multiple different binding sites on an antigen such as a virus. For example, some antibodies to COVID-19 will target binding sites on proteins in the outer shell while some may target nucleic acid (RNA) binding sites, but each will be specific and unique. Only when two different, but similar, viruses have identical structures will cross-reactivity occur. For example, if multiple strains of a coronavirus have maintained regions of nucleic acid that have not undergone mutation, an antibody that targets that region in one may target the identical region in another. This is why even if mutations occur between strains, antibodies that bind to areas that have not mutated are still effective. Conversely, an antibody that recognizes the measles virus generally cannot recognize the mumps virus.
Q: What does antibody testing tell me?
The antibody test (sometimes called a serology [blood] test) determines the types of antibodies present in the blood, that are produced by your immune system and that match the specific protein or antigen in question. Based upon the pattern of different antibodies present in your blood, your immune system’s ability to detect and therefore counteract the infection can be determined. Whether the presence of antibodies alone means that you have true immunity to the pathogen (bacteria, virus, etc.) is based upon a series of factors including the amount of antibodies your body produces as well as whether the pathogen changes or mutates significantly in the future, so as to make the antibodies less effective over time.
Given the time it takes for your immune system to generate antibodies after an exposure to the pathogen, antibody tests do not provide good information about whether you are recently or actively infected (e.g. you were infected in the last week or recently became symptomatic). Instead, antibody tests provide information about your past exposure to the pathogen, and your likely ability to combat future exposure to that pathogen.
Q: Is this test different than a “molecular test”?
Yes. A molecular test (sometimes called molecular testing or DNA/RNA testing) is a different type of test that uses different techniques to look for the presence of the genetic code, genes or genetic fragments that are present within the pathogen (e.g. virus). Fundamentally, this viral genetic test determines if the pathogen is currently present in your body. In other words, molecular tests determine if you have an active infection (even though you may not currently have symptoms). Unlike antibody tests, molecular tests do not tell you if you have been infected in the past nor do they tell you if your body has built up any immune defenses against the pathogen. Although molecular tests are critical in helping health authorities track and battle a disease like COVID-19, by determining who is currently infected, think of a molecular test as a ‘snapshot in time’. For example, a person who has had the infection in the past will generally have a negative result on molecular testing after they have recovered from the infection, even though they likely will have a positive test for antibodies for months or years after the molecular test is negative.
Q: Is an antibody test different than a swab test from my nose or mouth?
Yes. Nasal or throat swabs are generally used to obtain the pathogen itself (or its genetic components) and used for molecular tests. Because antibodies are present in your bloodstream, antibody tests require a small sample of blood. This may require venipuncture (blood drawn from the arm into a tube for delayed analysis) or a finger prick, for a test that can produce rapid results, in 15 minutes or less. Our test utilizes two small drops of blood from a single finger prick.
Q: How will this antibody test be performed?
Unlike some other antibody tests, this test requires just one or two drops of blood from a simple finger prick. The test is performed while you remain within the isolation and safety of your vehicle.
Q: Do I need to go to a lab facility or hospital for this antibody test?
No. This test is conveniently performed as a ‘drive-through’ test while you remain in your vehicle.
Q: How long does it take before my test results are ready?
Unlike some other antibody tests, results for this test are ready in just 10-15 minutes. The results will be provided to you before you leave the testing site.
Q: Do I need a prescription or Doctor’s note to receive this test?
No outside prescription or Doctor’s note is required for this finger prick test. If you wish to have the test, you can simply schedule online and proceed.
Q: Is this test covered by my insurance?
The vast majority of readily available antibody finger prick tests are not currently covered by insurance. You may always inquire about coverage for specific tests with your insurance carrier.
Q: Will antibody testing tell me if I have COVID-19 now, or if I am contagious?
The antibody test alone is not designed to determine whether you have the COVID-19 infection now, or whether you are currently sick with the virus that causes COVID-19. Furthermore, although the antibody test may give some hints about whether you may be contagious, that test alone will not determine if you are contagious.
Because the antibody test cannot be used as a diagnostic test for the virus by itself, it needs to be combined with other important information to determine if a person is actively and currently sick with COVID-19.
For example, an antibody test result that shows positive IgM antibodies but negative IgG antibodies in a person who also has flu-like symptoms, such as fever and a cough, may strongly suggest the person is currently infected with the COVID-19 virus and may also be contagious. This is due to the progression and timeline of antibody creation by the immune system. In this example, additional testing such as molecular testing (swab testing) may be recommended to help prove the current presence of the COVID-19 virus itself in the body.
Conversely, a molecular test alone will not prove that an individual will produce detectable levels of protective antibodies. That information requires an antibody test, as some individuals may not create adequate antibodies for a number of reasons (e.g. they have a problem with their immune system due to certain medications they may use).
In summary, these antibody tests are of limited value in the diagnosis or screening of a patient in whom a COVID-19 infection is suspected, because antibody tests cannot rule out presence of the virus. But positive results from appropriately validated serology tests that are designed to be very specific to the SARS-CoV-2 virus can provide evidence as to whether a patient likely has (for IgM antibodies), or has recovered from (for IgG antibodies) a COVID-19 infection. In addition, although not everyone who is infected will develop an antibody response, appropriately validated serology tests, when used broadly, can be useful in understanding how many people have been infected or exposed to the virus and how far the pandemic has progressed.
Serology tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who have been exposed to SARS-CoV-2 virus, and who therefore have developed an immune response. In the future, this testing may potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection. In addition, these test results can aid in determining who may donate a component of their blood, called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.
Q: Will antibody testing tell me if I am immune from getting COVID-19?
The answer to this common question is a bit more complex due to all of the factors that go into becoming “immune” from future infections.
In general, a person with demonstrated IgG antibodies to the pathogen in question has a level of protection or immunity that can help protect them against exposure and future infections to that pathogen. Therefore, a person who tests positive for COVID-19 IgG antibodies can be reasonably reassured that they have some level of protection against COVID-19 in its current form.
However, the level of your immunity, and how long it is likely to last, are also dependent upon the amount of antibodies your body produces in response to the pathogen during a future exposure. Also, your immune system’s ability to respond to the pathogen in the future may diminish over time. This is why, for instance, for those that have been vaccinated for certain diseases (such as tetanus) a periodic ‘booster shot’ may be required to stimulate the immune system to produce a new level of antibody protection that might have otherwise diminished over time.
Importantly, some pathogens have the ability to change or mutate certain components such as their outer proteins or antigens. Therefore, the virus that causes COVID-19 could change over time, thus making even a robust immune response to the original virus less effective against the new strain.
In response to an infection, such as COVID-19, the body develops an overall immune response to fight the infection. One component of the immune system's response is development of antibodies that attach to the virus and help eliminate it. The body's initial immune reaction produces general antibodies that attack many infections, called "IgM" antibodies. IgM antibodies indicate an active or recent infection. Because it takes time for the body to make IgM antibodies in response to SARS-CoV-2, the absence of IgM antibodies does not mean that the person is not infected. A test for IgM antibodies might also give a false negative result, i.e., the test is negative in a person who in fact has IgM antibodies or is starting to make them but has not made enough to be detectable on the test yet. This can occur in a patient with SARS-CoV-2, particularly during the early stage of the infection, while the person is actively shedding the virus. Since IgM antibodies may not develop early or at all in infected patients, this type of antibody test is not used to rule out SARS-CoV-2 in an individual.
Over time, the body develops a second type of antibody in response to the infection. This antibody, which is more specific to the virus, is called an "IgG" antibody. Most antibody tests detect IgG antibodies. On average, IgG antibodies take a few weeks after an infection to develop, but the time to development may vary substantially, and there is still a lot we do not know about SARS-COV-2. Since IgG antibodies generally do not develop until several weeks after infection, this type of antibody test, even though it is more specific to SARS-CoV-2, is not used to rule-out SARS-CoV-2 infection in an individual.
Q: How are different antibody testing sites and different companies different?
Some companies that make these tests are not located in the United States. In some cases, this may mean that they are subject to less stringent regulations for the tests, and for the factories in which they are produced. Some companies make data about their tests available for us to scrutinize and review, and some companies do not. The accuracy of various tests may also vary, and some tests may not perform at the level promised by the manufacturer. Finally, some tests require a blood draw from the arm into a tube (venipuncture) rather than a fingerstick. We have vetted dozens of companies to find a company that manufactures its tests in the United States, utilizes a finger prick for the blood sample, has a result time of about 15 minutes, and has provided data and test results that give us confidence in their tests.
Q: Are antibody tests FDA approved? Do they need to be?
As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution of tests to identify antibodies to SARS-CoV-2, where certain criteria have been met. The test we are offering is manufactured by an FDA-approved manufacturer and is in compliance with the FDA’s criteria. You should know the following facts about this test:
This test has not been reviewed by the FDA.
Negative results do not necessarily rule out current SARS-CoV-2 infection, particularly in those who have been in very recent contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in certain individuals, and your test report may recommend such a test.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform a decision about infection status. Again, a molecular test is the test of choice for diagnosis of active infection. This antibody test is not intended to serve that purpose.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. These are viruses around the world that rarely may cause your body to produce antibodies that can create cross-reactivity on some of these types of tests. It remains unclear if such cross reactivity provides any protection from COVID-19.
Q: Is the antibody test you utilize made in the United States?
Yes. Antibody tests are manufactured in many countries around the world. This test, however, is made in the United States by an FDA-approved, fully licensed diagnostic testing company and, under the scrutiny of US federal and State licensing authorities and standards.
Q: How do I know that this antibody test is accurate?
The use of a product made in the United States by an FDA-approved manufacturer is one piece of information that makes us comfortable about the product. Additionally, we have reviewed the data for the product with our statisticians and research team members, and we have compared the manufacturer’s data, and the quality of the data, with information from other companies around the world. We also have done a limited sample of testing ourselves to make sure the product performs as expected. No test is perfect however, and false positives and false negatives can occur with these tests.
Q: If my test shows that I don’t have any antibodies, what does that mean?
As with all diagnostic tests, the test results must be correlated with clinical findings. If the test result is negative for antibodies and coronavirus infection is still suspected, additional follow-up testing using other clinical methods (such as molecular testing) may be recommended. A negative test result does not rule out the presence of an active COVID-19 infection in the early stages, before the immune system has had the chance to produce antibodies. Therefore, negative results do not rule out a COVID-19 viral infection, particularly in those who have been in contact with the virus.
Q: Will this test detect antibodies for COVID-19 only?
This test is specifically designed to detect the presence of antibodies associated with the coronavirus that causes the COVID-19 disease, SARS-CoV-2.
However, positive antibody results may occur as a result of prior exposure to other, non-SARS-CoV-2, coronavirus strains such as HKU1, NL63, OC43, or 229E. These are viruses from around the world that might cause your body to produce antibodies that result in a positive result on our antibody test. It is not clear whether antibodies to these other viruses would provide any protection against COVID-19.
This test is intended for COVID-19. This test does not look for antibodies to other viruses (e.g. influenza, measles, mumps, herpes, etc.).
Glossary of Technical Terms
Antibodies
A type of protein made by the immune system after exposure to a pathogen. The immune system uses antibodies to target the pathogen, direct am immune response, and fight an infection
Antibody test
A blood test to detect the presence of antibodies against a pathogen.
Antigen
Biological molecules that are specifically bound by antibodies
Coronavirus
A common class of virus frequently associated with respiratory tract infections, ranging from the common cold to COVID-19
COVID-19
The disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
IgM; IgG
Types of antibodies. IgMs are more abundant, created in the early stages of infection, and are usually the initial line of antibody defense to infection; IgGs are responsible for long-term immunity to previously encountered viral and bacterial pathogens
Immunoassay
Test that utilizes antibodies to recognize specific antigens, including viruses; enables quick qualitative results
Immunoglobulin
Another term for antibody; often abbreviated “Ig”. Different types of immunoglobulins include the M (IgM) or G (IgG), which have different roles in the body’s immune response.
Molecular Test
Tests that use biochemical techniques to detect genes and genetic products
Pathogen
A generic term for an infectious agent, such as a bacteria or virus
Primary/secondary immune response
A body’s response to a pathogen. The primary response occurs upon the first encounter with the pathogen; the secondary response occurs upon subsequent encounters and involves immune system "memory" driven by IgG antibodies, which can recognize a pathogen from a prior infection.
SARS-CoV-2
The virus that responsible for the COVID-19 pandemic
Serological Test
A test that utilizes blood, or a component in blood, for testing.

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Symptoms & Health Information
Since January 1, 2020 have you had any of the following symptoms more than usual?
What approximate date did symptoms start?
Have you ever had a nasal swab or oral swab test for Coronavirus (COVID-19). This may have been called a genetic test, a viral test, or molecular test but would have been via only a swab of the nose or mouth or a saliva sample?
What was the result?
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Do you take any medicines that can suppress your immune system (examples include but are not limited to prednisone, Azathioprine (Imuran), Mycophenolate mofetil (Cellcept), Cyclosporine (Neoral, Sandimmune, Gengraf), adalimumab (Humira), or chemotherapy for treatment of active cancer)?
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