Antibodies are your immune system’s way of remembering how it responded to an infection so it can attack again if exposed to the same pathogen. People with antibodies for a specific virus have a lower risk of infection because their body has already created immune cells to fight it. By looking for these antibodies, specifically IgM and IgG, we can show if someone has already been exposed to a particular virus. IgM, the body’s largest antibody is seen about 7 days after you are infected and typically goes away over the next week or so. IgG, the most common antibody, starts to form when IgM starts going away and indicates you are recovering from the infection. When you are infected by SARS-CoV-2, also known as COVID-19 or coronavirus, your immune system produces IgM and IgG antibodies that are specific to COVID-19. If these specific antibodies are present and there are enough of them in your system to be detected, we have evidence your body has generated an immune response to the virus by producing antibodies to fight the infection. Which of these antibodies are present, if at all, can also tell us where you are in the infection process (early, active infection, recovering, or recovered and possibly immune) or if you may not have been exposed.

Antibody blood tests, also called serology tests, do not look for the actual virus in your system like a PCR swab test does after you provide a sample from your upper respiratory tract (nose or throat). Instead, this test uses a small amount of blood, typically from a finger stick, to detect if specific COVID-19 IgM and IgG antibodies are present in your system. These tests are important because they can tell us if a person was exposed to COVID-19 regardless if symptoms were present or the infection was asymptomatic.

Click here to read an Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2

Click here to read A Case for Broadening both PCR (Molecular) and Antibody Testing of COVID-19

Antibody testing should occur after you have had symptoms for at least 7 days, if you tested positive with a PCR swab test a week or more ago (even if you have recovered), or if you were exposed to someone with a confirmed case of COVID-19 at least 7 days before getting antibody tested (regardless of symptoms). The reason for this is to ensure your immune system has had enough time to generate antibodies so we can detect them with testing.

Yes. While most antibody tests have not been approved by the FDA, in times of national emergency, many manufactures of these test kits, including those used at our testing facility, have been issued an emergency use authorization (EUA) from the FDA after proving their test kits deliver reliable and consistently accurate results for detecting COVID-19 antibodies. Our test kit, Orient Gene, was approved by the FDA for emergency use as of June 1, 2020 and the next step in the process will be full FDA approval. Read press release here.

Orient Gene has already achieved CE status in Europe and has also been independently tested and verified by the WHO when they compared our test kits to the only FDA-approved antibody point-of-care test made by Cellex. In those studies, Orient Gene outperformed Cellex and others on sensitivity and specificity 7 days from symptom onset.

To further ensure the Orient Gene test kits used at our facility would perform as promised, we conducted our own internal study to confirm their statements. We learned early on in our internal study that these kits, when conducted in the right temperature and humidity-controlled environment (such as in the temporary buildings you see at the testing site), resulted as expected and published.  Once our study was complete, we began offering antibody blood testing using these kits to the general public. Please be aware other locations offering this type of testing may not have conducted an internal validation study to confirm their test kit’s accuracy. If you or someone you know has received or plans to receive antibody testing from another location, be sure to inquire if they have validated the accuracy of their test kits and how they did it.

If your test shows you have antibodies, we are confident to say you have likely been exposed to COVID-19. However, no test is perfect and negative results can occur if you have only had the virus for a few days. It is also possible to get exposed and not develop antibodies.

Click the image below to see a summary from the WHO study comparing our test kit (Orient Gene/Healgen) to others. Note that at the time of this study our test kit out performed Cellex (the only FDA approved LFA (lateral flow assy) antibody kit at the time of this study).

Click here to read the product insert for the Orient Gene/Healgen test kit.

Click here to read the WHO Study: Clinical sensitivity and specificity of three rapid SARS-CoV-2 Antibody (IgM/IgG) Tests on a hospitalized patient cohort: InTec, Cellex and OrientGene

Click here to read a Case Study by Dr. Thierry Prazuck on Orient Gene/Healgen on The Screening Test Performance

No. However, the FDA has issued and approved the manufacturer of our antibody blood test kit as an emergency use authorization, or EUA officially on June 1, 2020. Read press release here. An EUA is only issued from the FDA after proving the test kit delivers reliable and consistently accurate results for detecting COVID-19 antibodies. As a part of this strict process, the test kit must go through an application process that requires repeated submission of data and performance of the test kit. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that our antibody test was among the top performers.

To further determine if our test kit would perform as promised, we conducted our own internal study to confirm the manufacturer’s statements. We learned early on in our internal study that these kits, when conducted in the right temperature and humidity-controlled environment (such as in the temporary buildings you see at the testing site), resulted as expected and published.

Click here to read the EUA statement from the test kit manufacturer.

The cost of antibody testing includes the test kit itself, staff to collect the test, all of the PPE, equipment, supplies, and infrastructure needed to administer and support testing, your teleconference with our medical providers, and everything else you see at our drive thru testing location. All pricing is based on specific codes used for testing and Medicare rates established by the government. If you have insurance, you will not have any out-of-pocket expenses for testing.

The antibody test takes about 15-20 minutes to produce results. You will be called by one of our medical providers the same day that you take your test to go over results. Please note it may take several hours to receive your phone call due to the number of patients our providers are calling but you will receive a phone call the same day of your test.

Not exactly. A good way to illustrate this point is to think about when you see damage to an area that was caused by a tornado. Because we all know what tornadoes can do and what the devastation looks like, even if we don’t see the actual tornado, we can make a pretty good assumption that a tornado touched down somewhere nearby and caused all the damage. The presence of antibodies allows a similar assumption. If we see COVID-19 specific antibodies, we can assume you have been exposed sometime in the past to coronavirus because these antibodies wouldn’t be present otherwise. However, because we are not testing for the virus itself and only the body’s response to the virus, these tests are not used to diagnose COVID-19 infections.

If you have the COVID-19 IgG antibody, you may have some level of immunity to coronavirus. However, because the virus is so new, experts do not know how long these antibodies might protect you. Some scientists think COVID-19 antibodies provide up to 6 months of protection against future exposure.

Click on photos for full size.

Antibody tests by themselves cannot confirm if you are cleared to go back to work because it is only half the picture. While antibody tests can show how common COVID-19 is in a population and how much it has spread based on the number of people with COVID-19 antibodies, it doesn’t tell you if you still have the virus in your system. Furthermore, if you are early on in your infection your immune system may not have had enough time to make these antibodies.

The hope is after enough time has passed, people with COVID-19 antibodies can safely get back to work and normal life, but more research is needed. At America’s ER, we believe antibody testing, when combined with serial PCR swab testing, provides the best picture to make that determination. The CDC serial testing strategy currently requires two negative PCR swab tests to clear you for work. America’s ER is dedicated to following CDC guidelines, but wants to take it a step further by introducing the antibody test to the equation to provide a clearer picture for governmental authorities to make that determination. This is why we always recommend PCR swab testing in conjunction with antibody testing.