What is EUA Approved? Learn more on the FDA site here
Frequently Asked Questions: Coronavirus Antibody Testing
(Due to high call volumes and requests, please carefully review the following information and we vow to get all of our patients serviced in a timely manner)
* How does the antibody test work?
o The antibody test checks your blood for any traces of the blood proteins (antibodies) your body will have produced if you were exposed to or infected with the virus.
o To run the test, we will need to draw a small amount of blood from you at one of our Leaf locations. The sample is then sent to Quest Laboratories, who are conducting the actual test on your blood.
* Who is eligible to test for Coronavirus antibodies?
o The New York State Department of Health has issued guidelines on who they would like to receive this testing.
o To find out if you are eligible, you would need to book a telemedicine visit with one of our physicians.
o The physician would evaluate you to determine if you fit criteria provided by the New York State Department of Health.
o If you fit criteria, you will be guided through the next steps for testing.
* Can my entire household be screened to see if we are eligible to take the antibody test?
o Yes, but you must all be screened individually. We book one telemedicine screen per patient.
o You will then be asked to come in to have your blood drawn.
o Children must book with pediatricians or family medicine doctors.
o Adults must book with internists or family medicine doctors.
* What test is Quest Diagnostics using, how does it work, what does it measure, and what do the results look like?
o It is our understanding from our Quest Representative, that Quest Diagnostics is using the Abbott Laboratory SARS-CoV-2 Serology (COVID- 19) Antibody (IgG), Immunoassay test.
o Quest Diagnostics uses a test that has been granted an Emergency Use Authorization (EUA) by the FDA. An EUA is granted by the FDA when there is a public health emergency and the ability diagnose, treat, or prevent serious or life-threatening diseases is needed right away. To be granted FDA approval, the test must be studied over a longer period of time.
o “Test sensitivity” is the ability of a test to correctly identify those with the disease (true positive rate).
o “Specificity” is the ability of the test to correctly identify those without the disease (true negative rate).
o Abbott Laboratory’s test is shown to be 100% sensitive (true positives for COVID-19) at Day 14 of illness or later and 99.6% specific (true negatives for COVID-19).
o Please note that the 'Reference Range' refers to what is considered to be a 'normal' value. Since the test is reported as a qualitative result (i.e. positive, negative), the reference range is 'negative' instead of a numerical range (i.e. 0-100)
o Please see the FDA site for more information about an EUA: https://www.fda.gov/emergency-preparedness-and-response/mcm- legal-regulatory-and-policy-framework/emergency-use-authorization
* How long does it take to get results?
o Quest is releasing the results within 4 - 5 business days. You will be notified by our office either electronically or by phone of your result, once it is received.
* If I test positive, does this mean I have immunity?
o No. Detection of Covid-19 IgG antibodies may indicate exposure to COVID-19.
o An IgG positive result may suggest an immune response to a primary infection with COVID-19, but the relationship between IgG positivity and immunity to COVID-19 has not yet been firmly established.
*If I test positive, can I visit my family?
o No. Regardless of the result of your test, we must adhere to social distancing guidelines established by our local, state, and federal governments. Please continue to refrain from any gatherings outside of your own immediate household. It's difficult to miss our loved ones, but we are still in the process of slowing the spread of the virus.
* How much does the antibody test cost?
o Your telemedicine screen is covered by most insurance plans at 100%, including your co-pay. As per Quest Diagnostics, the blood test is being covered by the government at 100% whether or not you have insurance. You may call your plan to confirm. If you do not have insurance the cost for your telemedicine screening is $200, which includes blood draw should you require one for testing.