Why Should I Take the Antibody Test?
The antibody test assists individuals and healthcare providers in determining if they have been exposed to COVID-19 and developed a detectable immune response to it.
This data will allow scientists to better understand the disease and help shape actions such as shelter in place, return to work, and ultimately vaccines.
Those individuals who test positive for antibodies have developed detectable antibodies to COVID-19. They can possibly help others by donating plasma to infected individuals who can use the antibodies in others blood to help fight the virus.
What Is The COVID-19 Antibody test?
The COVID-19 IgG/IgM Whole Blood Rapid Test Device we are using utilizes lateral flow technology. The test is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies.
IgM antibodies are developed during the early onset of exposure to COVID-19 (< 2 weeks).
IgG antibodies are developed later on (2-4 weeks)
What Are Antibodies?
Antibodies are a blood protein produced in response to and counteracting a specific antigen. Antigens are substances which the body recognizes as alien, such as bacteria, viruses, and foreign substances in the blood. Antibodies bind to these antigens in a lock and key fashion.
In general, antibodies can be detected 1-3 weeks after infection. This antibody test is intended to screen individuals for prior exposure to COVID-19 by looking for an immune response.
According to the U.S. Food and Drug Administration (FDA), COVID-19 antibody testing may indicate, “the person has been exposed to the COVID-19 virus and developed antibodies against it, which may mean the individual has at least some immunity to the coronavirus.”
“Antibody testing has the potential to help healthcare professionals identify people who have been exposed to COVID-19 and who have developed an immune response,” said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. “In addition, FDA has indicated that antibody testing can help identify those who could contribute a part of their blood, called convalescent plasma, which may provide an avenue for possible treatment for those who are seriously ill from the coronavirus.”
Our antibody test uses whole blood specimens obtained by fingerstick.
Does This Test For COVID-19?
Not specifically. Those who test positive for antibodies will then get tested by RT-PCR for COVID-19 by their health care provider. The gold standard test for actively shedding COVID-19 virus is the RT-PCR test. Combining RT-PCR with antibody tests can significantly raise the sensitivity for detecting actively shedding COVID-19 in infected individuals.
Are Antibody Tests FDA Approved?
The short answer is no. COVID-19 antibody tests are not currently FDA approved. There hasn’t been enough time. FDA approval can take weeks, months and years.
The tests we use are marketed under FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 for FDA Emergency Use Authorization (EUA). These tests have been independently validated.
A CLIA waiver is currently not required for this testing.
Can I Take the Test At Home?
No. This product is intended for professional use and not for home use. Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform of infection status.
A negative result may appear and not correlate with symptoms. A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.
Who Can Be Tested?
Test collection is available only to patients who:
- Are asymptomatic; have been asymptomatic for at least 10 days;
- Lack a fever (as assessed by non-contact thermometer checks at time of visit);
- Are wearing a face mask.
How Do I Schedule?
Appointments for antibody testing should be scheduled ahead of time through the Body Lounge Park Cities website (www.BodyLoungeParkCities.com)
Patients suspected of having or confirmed to have active COVID-19 infection or disease should not visit Body Lounge Park Cities, which is not equipped to collect the necessary respiratory specimens for molecular COVID-19 diagnostic testing. Patients who believe they may have COVID-19 are strongly encouraged to contact their healthcare provider.
How Is Testing Conducted?
Testing at Body Lounge is very straight forward.
- Schedule your appointment time online (BodyLoungeParkCities.com)
- You will check-in at your appointment time. To avoid crowding, please do not arrive early. Please wear a mask.
- Your temperature will be taken with a skin gauge thermometer
- Your information will be confirmed
- You will proceed upstairs to the clinic. When a room opens up a doctor or nurse will administer the test
- Any questions will be answered
- If you test positive for antibodies, you will be notified within 12 hours
What Does A Positive Test Look Like?
The testing kit looks similar to a pregnancy test. Once the blood is collected a buffer solution is added and allowed to ‘cook’ for 10 – 15 minutes.
Test results should be interpreted in connection with other factors, such as symptoms and history. Results signify that antibodies are present, but protective immunity based on these results has yet to be established in clinical trials. Antibody tests by themselves are of limited value in the immediate diagnosis of a patient where COVID-19 infection is suspected.
How Sensitive and Specific Is This Test?
- The sensitivity of the test is 89.4% when compared to RT-PCR (COVID-19 gold standard).
- The specificity of the test is 97.7% during the convalescence period and specificity when compared to RT-PCR (COVID-19 gold standard)
For an understanding of how specificity and sensitivity is calculated, please visit our blog
What Is A Good Test?
There is no ‘good test’.
If your results are:
IgM negative, IgG negative: Individual does not have detectable antibodies to COVID-19 . A medical professional should observe symptoms and epidemiology of the individual. If symptoms warrant, a RT-PCR test should be performed.
IgM positive, IgG positive/negative: Acute or recent infection. Should be combined with RT-PCR test to rule out actively shedding infection.
IgM negative, IgG positive: Previous, distant infection. Should be combined with RT-PCR test to rule out actively shedding infection.
Those that test positive may be eligible to donate plasma to help someone suffering from the disease.
For those that test positive and are interested in donating plasma, Body Lounge will provide a contact for you to determine your eligibility.
If I Test Positive, What Should I Do?
You will be contacted by one of our doctors for the next steps. We recommend having the RT-PCR test to rule out actively shedding COVID-19. If positive, we will provide you with a slip that states when you were tested, what test was used, and what the results were so that you may have the RT-PCR test performed.
What is the Cost?
At many labs and clinics, the cost of the antibody tests is over $150 – $200 per person.
At Body Lounge Park Cities, the cost of the test is $65 per person.
About Body Lounge Park Cities
Body Lounge is a boutique multidisciplinary medical clinic located in Snider Plaza. We are locally owned and operated with owners and medical staff all living in University Park. We help people take action to improve health outcomes. We offer modalities and procedures to help the immune system function and help you live your optimal life so you can feel, move and look better.