IMPORTANT: PLEASE READ
What can this test tell me? Will this tell me if I’m immune to COVID-19?
To detect and/or diagnose COVID-19, Global 7 Diagnostics utilizes the DTPM COVID-19 RT-PCR Test (the “Test”). The Test has been authorized under the Food and Drug Administration’s (“FDA”) Emergency Use Authorization (“EUA”). The Test has not been FDA cleared or approved. The Test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19, as determined by the Secretary of the Department of Health and Human Services under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the EUA is terminated or revoked sooner. The Test is limited to United States laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), 42 U.S.C. §263a, to perform moderate complexity tests, and in United States laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the Test. As with any complex clinical laboratory test, there is a nominal possibility of failure or error in analysis. Extensive measures are taken to avoid these errors.
Positive results are indicative of the presence of SARS-COV-2 nucleic acid; clinical correlation with patient history and other diagnostic information are necessary to determine patient infection status. A patient obtaining a positive result should seek physician consultation immediately. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-COV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
For the most up to date information on COVID-19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage at https://www.cdc.gov/nCoV
I feel like I was exposed to COVID-19 yesterday, should I get tested today?
It is recommended that you wait 3 to 5 days after a presumed exposure. If you are currently experiencing COVID-19 like symptoms we recommend contacting your healthcare provider immediately.
What are coronaviruses?
Coronaviruses (“COV”) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (“MERS-COV”) and Severe Acute Respiratory Syndrome (“SARS-COV”). The novel coronavirus (“SARS-COV-2” or “COVID-19”) is a new strain that has not been previously identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing
and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death
can occur.
What is COVID-19?
COVID-19 is caused by the SARS-CoV-2 virus. The virus can cause mild to severe respiratory illness and has spread globally, including the United States. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, headache, sore throat or new loss of taste or smell.
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.
Hotline: (844)-442-2681
1. What is the DTPM COVID-19-RT-PCR Test?
The test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal or oral swabs.
2. Why was my sample tested?
You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:
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You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, and/or
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You have been in close contact with an individual suspected of or confirmed to have COVID-19.
Testing of the samples will help find out if you may have COVID-19.
3. What are the known and potential risks and benefits of the test?
Potential risks include:
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Possible discomfort or other complications that can happen during sample collection.
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Possible incorrect test result (see below for more information).
Potential benefits include:
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The results, along with other information, can help your healthcare provider make informed recommendations about your care.
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The results of this test may help limit the spread of COVID-19 to your family and others in your community.
4. What does it mean if I have a positive test result?
If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
5. What does it mean if I have a negative test result?
A negative test result means that the virus that causes COVID-19 was 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. This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, 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.
6. Is this test FDA-approved or cleared?
No. This test is not 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. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).
7. I don’t feel sick, will this test work on patients without symptoms?
Anyone can take the test, however it is recommended you wait 3-5 days after a presumed exposure.
8. Can my insurance pay for this test?
At this time we are currently not accepting insurances.
9. How much does this test cost?
$135, subject to change due to short supply
10. 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.
11. 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.
12. 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.
13. 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.
14. What is your return policy?
All sales are final.
