IMPORTANT: PLEASE READ
What can this test tell me? Will this tell me if I’m immune to COVID-19?
It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior exposure. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.
Results are for the detection of exposure to SARS-CoV-2. Exposure to SARS-CoV-2 is generally detectable in blood several days after an initial infection, although the duration of time that antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for COVID-19 IgG/IgM Rapid Test Cassette may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.
The COVID-19 IgG/IgM Rapid Test Cassette is only for use under the Food and Drug Administration's Emergency Use Authorization.
The test we are using generates a qualitative response (Positive/Negative), thus we must establish and test for antibodies above a threshold that indicates a past or recent infection. If the test showed positive for anyone who has had the virus, we wouldn’t be able to differentiate between those patients and those who are at risk for being ill and/or potentially spreading and those who were ill five weeks ago and are no longer facing the same risks.
I feel like I was exposed to COVID-19 yesterday, should I get tested today?
We recommend that you wait at least five (5) to ten (10) days after a presumed exposure before undergoing our screening. The reason for this is due to the fact that the body needs to generate the antibodies that are detected by the test. If a patient is tested too early, this could lead to a false-negative or an inconclusive result when in reality the body is simply ramping up its immune system for defense.
What are coronaviruses?
Coronaviruses are a large group of viruses that can cause illness in animals and humans. Some coronaviruses commonly circulate in the United States and usually cause upper respiratory symptoms such as cough or runny nose, although some can cause more serious illness. The 2019 novel (new) coronavirus causes the illness coronavirus disease 2019 (COVID-19).
What is COVID-19?
Coronavirus Disease 2019 (COVID-19) is a disease that was identified in Wuhan, China, and is now being spread throughout the world. People are encouraged to take common-sense precautions to prevent the spread of all infectious diseases, including COVID-19.
Wash hands frequently with soap and water for at least 20 seconds at a time.
Avoid touching your eyes, nose, and mouth with unwashed hands.
Avoid close contact with people who are ill.
Cover your mouth and nose with a tissue when you cough or sneeze.
Do not reuse tissue after coughing, sneezing or blowing your nose.
Clean and disinfect surfaces that are frequently touched.
How does COVID-19 spread?
Coronaviruses like COVID-19 are most often spread through the air by coughing or sneezing, through close personal contact (including touching and shaking hands) or through touching your nose, mouth or eyes before washing your hands. Please visit the URL for the Centers for Disease Control and Prevention (CDC) about how COVID-19 spreads and how to protect yourself and your community from getting and spreading respiratory illnesses.
Exposure and symptoms
Symptoms of COVID-19 are fever, cough, and shortness of breath. Symptoms may appear 2-14 days after exposure.
The State of Georgia has a COVID-19 hotline. If you believe that you are experiencing symptoms of COVID-19 or have been exposed to the novel coronavirus, please contact your primary care doctor, an urgent care clinic, or your local federally qualified healthcare center. Please do not show up unannounced at an emergency room or health care facility.
1. What is our test?
The sudden 2020 outbreak of novel coronavirus disease (COVID-19) has spread rapidly throughout the globe and has become the chief concern of health officials both here in the United States and abroad. This coronavirus variation and the full extent of its disease profile were unknown prior to the pandemic, and medical research facilities and laboratories have been working tirelessly to develop testing systems that can help both officials and consumers have the ability to accurately screen themselves to help prevent further spread of the virus. As testing materials become available, we at Global 7 Diagnostics believe that it is important to give individuals the opportunity to have themselves tested for the benefit of themselves, families, and communities.
A majority of current testing available involves a highly complex DNA analysis in order to determine if a patient has been exposed. The cost and availability of this methodology aren’t available or practical for all applications as they currently stand. Using antibodies produced by the body’s immune system to detect a reaction to COVID is a practical and more cost-effective alternative that we believe has widespread application as an easy-to-use and accurate testing method that is able to produce results with very short turnaround times.
2. You mentioned DNA, is this a DNA test?
No, this particular test is based upon antibodies produced by the human immune system. Specifically, the Immunoglobulin M and G (IgM/IgG) are used in this test to detect the presence of COVID-19 antibodies in the human body.
3. What type of sample does this test work on?
Currently, the test supports whole blood, blood serum, and blood plasma samples. In order to minimize the steps involved and maximize comfort and convenience to the patient, we will be using whole blood.
What this means for a patient is that only a small vial of blood needs to be collected in order to conduct the testing. The sample collected should have enough volume to conduct a retest in the event that one is required. In the rare event that a blood redraw is needed, our staff will contact you to set a new appointment time that is convenient for you.
4. What does the FDA say about the test?
It is important to note that while the FDA is making special allowances for newly developed COVID tests, many are still awaiting FDA approval under the guidelines of the recently issued Emergency Use Authorization. Prior to final approval by the FDA, no test; COVID or otherwise, is legally allowed to be used as a diagnostic test in a clinical setting. Because of this distinction, it is extremely important to note that, from a patient perspective, results produced by this test can not be considered a diagnostic by a physician or hospital and would not be able to recommend treatment solely based on these results. Patients must treat these results as informational only.
5. Informational Only? Does that mean this test isn’t real?
No, this simply means that the test hasn’t been approved for use as a diagnostic by the FDA yet. The test has already been submitted for FDA approval as-is and is currently undergoing evaluation. It has been in development since the initial outbreak in Wuhan and in conjunction with the Chinese CDC. This is important to note as the test was developed using and performed on known positive COVID-19 patients and carries with it a sensitivity and specificity of 95% and 91% respectively when both IgM and IgG are tested.
Like any test prior to FDA approval, test results should not be used as the sole means of diagnosis and treatment. Any patient who suspects that they are infected or a carrier should seek confirmatory testing in a clinical setting to be sure. It should be noted that COVID-19 may not be detected even though COVID-19 antibodies are present in the sample and could lead to a false negative. This could occur if the amount of COVID-19 antibody present is lower than the limit of detection of the test. In order to minimize the occurrences of false-negatives, both IgM and IgG testing is conducted.
Please review our terms of service if you have additional questions.
6. IgM and IgG? Which one is being tested?
We believe that it is important to test for both antibody types when attempting to screen a patient for COVID-19. This is due to the fact that the body utilizes certain antibodies over others depending on how much time has passed since exposure. IgM detection is more helpful for patients more recently exposed while IgG is better for those who have been a carrier for several days.
Testing for just one could easily lead to a misleading result and thus we consider testing both simultaneously to be the best approach overall and the best way to avoid false-negative results.
7. I don’t feel sick, will this test work on patients without symptoms?
Yes! Thankfully the human body produces antibodies regardless of a patient displaying symptoms. This is especially important to note as many individuals would not consider themselves infected or a carrier simply due to a lack of symptoms. This increases the likelihood of spreading the infection to those who might be more susceptible to the virus overall.
8. Can my insurance pay for this test?
Insurance carriers will only provide reimbursement for tests designated as a clinical diagnosis tool by the FDA. As explained previously, our test must be designated as “For Informational Use Only” until final FDA approval has been granted. As COVID-19 tests are being developed and waiting for approval, we wanted to offer a non-insurance route for those who want testing and results now.
9. How much does this test cost?
We are currently offering this testing service for an out-of-pocket cost of $105.00. This price includes both IgM and IgG testing. The price is subject to change.
11. Can I book multiple people for the same appointment?
In order to ensure a smooth flow of sampling and testing, we ask that any individual who would like testing to book their own appointment time so that we can better account for patient volume throughout the day.
12. I would like my entire family to be tested, how do we do this?
If a family member is at least 18 years of age, we ask that they create an account and book an appointment separately. If you are concerned about lack of availability, please contact our staff at (470) 300-1191 and they will assist with scheduling for large parties.
13. I want to have my child tested, is that ok?
Yes! As the patient interaction purely consists of a blood draw, it is appropriate for patients of all ages.
As your child will not be able to create an account and pay for testing on their own, please contact our staff at (470) 300-1191 and let them know that you would like additional testing for your child added to your account. Your information and balance will be updated accordingly.
14. How will I get my results?
Results will be provided via .pdf in the account you created initially. You will receive a notification via email when they are available for your viewing.
15. I tested negative, does this mean I’m in the clear?
You may not have ever had COVID-19. Talk with your healthcare provider about your test result and the type of test you took to understand what your result means.
You could still have a current infection.
The test may be negative because it typically takes 1–3 weeks after infection for your body to make antibodies. It’s possible you could still get sick if you have been exposed to the virus recently. This means you could still spread the virus.
Some people may take even longer to develop antibodies, and some people who are infected may not ever develop antibodies.
If you get symptoms after the antibody test, you might need another test called a viral test.
Regardless of whether you test positive or negative, the results do not confirm whether or not you are able to spread the virus that causes COVID-19. Until we know more, continue to take steps to protect yourself and others.
16. I tested positive, does this mean I have COVID-19?
A positive test result shows you may have antibodies from an infection with the virus that causes COVID-19. However, there is a chance a positive result means that you have antibodies from an infection with a virus from the same family of viruses (called coronaviruses), such as the one that causes the common cold.
Having antibodies to the virus that causes COVID-19 may provide protection from getting infected with the virus again. If it does, we do not know how much protection the antibodies may provide or how long this protection may last.
Talk with your healthcare provider about your test result and the type of test you took to understand what your result means. Your provider may suggest you take a second type of antibody test to see if the first test was accurate.
You should continue to protect yourself and others since you could get infected with the virus again. If you work in a job where you wear personal protective equipment (PPE), continue wearing PPE.
You may test positive for antibodies even if you have never had symptoms of COVID-19. This can happen if you had an infection without symptoms, which is called an asymptomatic infection.
17. What is your return policy?
All sales are final.