COVID-19
COVID-19 screens can answer important questions about your health, giving you the information you need to make the right healthcare and lifestyle choices for improved wellness.
COVID-19 is caused by the SARS-CoV-2 virus. The COVID 19 IgG Antibody test is designed to detect antibodies in a blood sample that would indicate that you may have or previously had a COVID-19 infection.
Requirements: Must be asymptomatic (without symptoms) for at least 14 days prior to testing
What does it mean if I have a positive test result?
If you have a positive test result, it is likely that you have or previously had COVID-19 and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, including any previous symptoms, possible exposure to COVID-19, and the location of places you have recently traveled. There is also the chance that this test can give a positive result that is wrong (a false positive result).
It is not known if the antibodies that result from SARS-CoV-2 infection will provide someone with protection (immunity) from getting infected again. If antibodies do provide immunity, it is not known how much antibody would be required to do so or how long protection might last.
What does it mean if I have a negative test 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 infection. A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection. If this is the case, 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.
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).
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This test is used to confirm or rule out active COVID-19 infection.
This test is authorized by the FDA under an Emergency Use Authorization (EUA). a
This COVID-19 test may be helpful for those who:
- Currently have symptoms of COVID-19
- Live or work in a place where people reside, meet, or gather in close proximity (this can include healthcare settings, homeless shelters, assisted living facilities, group homes, prisons, detention centers, schools, and workplaces)
- Have been in close contact with someone who has a confirmed case of COVID-19
- Have been identified as someone who should get tested by an employer, public health department, contact investigator, or healthcare provider
- Are visiting a place that requires testing prior to arrival
- Do not have symptoms or known exposure to COVID-19, but who are unknowingly infected
This COVID-19 test may not be helpful for those who:
- Currently have severe symptoms that limit daily activities. Seek medical attention right away if this is the case.
- Have tested positive for COVID-19 in the last 3 months. When you test positive, you will not need to be tested again for 3 months as long as you do not develop new symptoms.
Understanding Results
If results are positive, it is important to contact your healthcare provider immediately, self-isolate, and monitor symptoms.
If results are negative, the individual was most likely not infected with COVID-19 at the time of sample collection. In some cases, there is not enough SARS-CoV-2 RNA in the sample to detect the virus. This can happen in a percentage of cases during the different stages of infection. If symptoms are present, it is important to follow up with a healthcare provider for further evaluation and to take protective measures to avoid infecting others.
About COVID-19
COVID-19 is highly contagious. Cases of COVID-19 range from mild to severe. Most people infected with this virus have mild symptoms. Some people who are infected don’t have any symptoms and don’t feel sick but can still transmit the virus to others. More severe cases of COVID-19 have been seen in older adults and those with weakened immune systems or pre-existing health issues; however, serious illness can also occur in younger adults. While fewer children have been sick with COVID-19 compared to adults, they can also be infected and serious illness can occur.
For more information on COVID-19 and COVID-19 testing, please visit one the following valuable resources:
- Centers for Disease Control and Prevention: About Coronavirus Disease 2019
- Center for Disease Control and Prevention: COVID-19 in Children and Teens
- World Health Organization: Coronavirus
This test, when ordered by the patient, is the patient’s responsibility and may not be submitted to insurance companies for reimbursement.
a This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while Hancock Regional Hospital has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA-cleared or -approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use on in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(B)(1) of the Act, 21 U.S.C. § 360BBB-3(B)(1), unless the authorization is terminated or revoked sooner. Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.
b Severe symptoms may include, but are not limited to, persistent fever (lasting longer than 48 hours) greater than 102 °F or a persistent low-grade fever, severe shortness of breath or difficulty breathing, continuous pain or pressure in the chest, severe coughing spells or coughing up blood, abdominal (gut) pain, neck pain, rash, bloodshot eyes, irregular heartbeat, confusion, blue lips or face, dizziness, lightheadedness, feeling too weak to stand, feeling very tired or lethargic, slurred speech or seizures, persistent vomiting or diarrhea, or feeling not well enough to stay home.
c There are many causes of fever, cough, and shortness of breath. COVID-19 is just one condition that may cause these symptoms. This test does not rule out the possibility of other illnesses and infections that may be present instead of or in addition to COVID-19.
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