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EUA FDA Approved COVID—19 Antibody Testing Available

At ASPI Biologics, we have one of the only EUA FDA Approved Antibody Tests available. The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is intended for qualitative detection of antibodies indicative of SARS-CoV-2 infection and is to be used as an aid for diagnosis of SARS-CoV- 2 infection. The Cellex Covid – 19 Rapid Serology IgG/IgM Test kit has an impressive 99% concordance rate when whole blood specimen is used which means you can be assured that your results are accurate and there is very little change of any false positive/negatives.

ASPI COVID-19 Antibody Testing FAQ

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Severe Acute Respiratory Syndrome (SARS-CoV). SARS- CoV-2 is a new strain that has not been previously identified in humans. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Several known coronaviruses are circulating in animals that have not yet infected humans. 2019 Novel Coronavirus (SARS-CoV-2) is a coronavirus identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Patients with SARS-CoV-2 report a mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. There is an urgent need for rapid tests to manage the ongoing pandemic. We are using the Cellex qSARS-CoV-2 IgG/IgM Rapid Test which is intended for qualitative detection of antibodies indicative of SARS-CoV-2 infection and is to be used as an aid for diagnosis of SARS-CoV- 2 infection. The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider. The qSARS-CoV-2 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

It is important to note that you may have the virus and still be negative to the immunity test, because it is only testing for immunity to the virus, not actual presence of the virus.  If your antibody test is negative, you may be in the early stage (first 3-7 days) of contracting the virus and have not yet created and antibody response to the virus.

There are many different tests being offered for antibodies at this time, and it is confusing to know which are giving you the highest quality results. ASPI Biologics has spent a tremendous amount of time researching and vetting most of the testing modalities out there. In general, most of the antibody tests being offered locally are in drive by testing facilities or with a concierge doctor coming to your home. They take a blood spot (a small finger prick of blood) which is highly inaccurate because capillary blood in your finger tips is highly unreliable especially when it comes to looking at antibodies in your body.

These tests are very concerning for many reasons. First, most of these are being flown in from China and there is very little evidence or research about whether they are accurate or not. Most have not submitted data to the FDA to validate them or have been denied by the FDA for approval.

The test offered at ASPI Biologics is very different. It was developed by a large, well respected lab that specializes in antibody testing.  The test measures for two different antibodies (IgM and IgG) giving us much more data to look at when interpreting the results.

The test is administered by you visiting us at ASPI and our medical personnel obtaining a blood sample via a blood draw in your arm. You do not need to fast or have any special preparation for the test. One small vial of blood is obtained and used for testing. Your visit to ASPI is less than 10-15 minutes. Currently, there is no at home test available.

All asymptomatic people (i.e. no fever, cough or sneezing) over the age of 15 who are able to tolerate a blood draw from a vein in the arm.

ASPI has implemented strict safety protocols, guided by the Hillsborough County Health guidelines. You will notice upon entering the building that a full questionnaire as well as your temperature will be taken. In addition, we ask all clients visiting the facility to have no active symptoms of respiratory illness (fever, cough, sneezing) that could lead to spreading respiratory droplets at the facility.  All surfaces are cleaned with medical grade cleaning supplies after each visit. We aim to make the visit safer than a visit to your grocery store.

You will receive your results same day. The test takes 20-30 minutes to complete so within one hour after your visit you will receive an email from our team with your detailed report along with a guide for interpretation. This will help you decipher the results and consider next steps. Please forward the results to your primary care physician and discuss them with him/her as well. It is important that you keep them appraised of your current condition, especially if you are symptomatic

This test has been approved for EUA use effective April 1, 2020. Above you will find the FDA approval letter to Cellex for this test. The Cellex Covid – 19 Rapid Serology IgG/IgM Test kit has an impressive 99% concordance rate when whole blood specimen is used (which is why we don’t use a finger prick).  There are currently no FDA cleared tests on the market as it takes months to get full FDA clearance, therefore EUA approval through the FDA is currently the best option

Potential risks include: Possible discomfort or other complications that can happen during sample collection. Potential benefits include: the results, along with other information, can help your healthcare provider make informed recommendations about your care and the results of this test may help limit the spread of COVID-19 to your family and others in your community.

A negative test result means that the antibodies to 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 active COVID-19. 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. This means that you could possibly still have COVID-19 even though the test is negative. 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

The test has several possible results. Depending on the result, it may be more likely that you have COVID-19 and that you may need isolation to avoid spreading the virus to others. Other results may indicate you were infected previously. Your healthcare provider will work with you how to determine how best to care for you based on the test results along with other factors of your medical history, and your symptoms, possible exposures, and geographic location of places you have recently traveled.

We are charging $197 for the test. This includes the laboratory fee of $149 and our draw fee (which is the cost of our on-site medical staff, providing them with supplies and PPE, and administrative staff to handle the backend result reporting and appointment booking). We have kept the cost as low as possible so that as many people as possible can get tested. Of course, we wish we could offer it for free, but unfortunately, we are not subsidized by any insurance, government or hospital system.

Insurance, at this time, does not cover the cost of the test. We hope this will change soon so that testing can become widely available to our population and we can flatten the curve of the virus with greater speed and accuracy.