Frequently Asked Questions

What is Xera Med Research?

Xera Med Research is a private research lab in Boca Raton (with a satellite location in Fort Lauderdale) who services Pharma and Diagnostics Research & Development efforts. We are an FDA regulated and IRB approved research facility established in 2015. Our main objective in offering testing is to identify COVID-19 positive patients to donate plasma or blood for clinical research purposes.



What is COVID-19?

SARS-CoV-2 is the virus that has been named COVID-19. Coronavirus (COVID-19) is an illness caused by a virus that can spread from person to person. For more information on COVID-19 and how to help slow the spread, visit www.cdc.gov



Why would I want to know if I have COVID-19 antibodies?

For starters, knowing that you have COVID-19 antibodies tells you that you have had the virus and your immune system was able to handle the virus, possibly without you even noticing any symptoms.



How much does the COVID-19 PCR swab test administered by Xera Med Research costs?

We are a private research lab, not a government testing site nor a hospital. We provide our own staffing, PPE, lab supplies, and other resources to administer the tests. We are offering testing to the public at various price points depending on various factors. Please refer to our booking page for list of tests and pricing. At this time we do not accept medical insurance, but are able to issue you a receipt for you to submit to your carrier for reimursement.



What is the difference between COVID-19 PCR swab test and COVID-19 ANTIBODIES test?

The COVID-19 PCR test (nose swab) collects physical pieces of coronavirus from the back of the nose where it meets the throat. THis test can detect if you currently have an active COVID-19 in your system. A positive result indicates that viral genetic material is present. A negative result indicates that the SARS-CoV2 virus that causes the COVID-19 disease was not found. It is possible to have a very low level of the virus in the body with a negative test result. The COVID-19 ANTIBODIES test (blood draw) is designed to detect antibodies (immunoglobulins, IgG and IgM) against the coronavirus that causes the disease called COVID-19. Antibodies are proteins produced by the immune system in response to an infection and are specific to that particular infection.



How is COVID-19 ANTIBODIES test done?

Xera Med Research performs venipuncture blood draw to obtain blood for the antibody test. We collect 3-4 vials of blood, all in a single draw. This is very similar to going to your doctor for routine blood tests. We use some of the vials to perform the antibodies tests and the other ones are used for research.



How long does it take to get my results?

COVID-19 PCR test (swab) standard turnaround time is 3-5 busienss days. COVID-19 PCR test (swab) HOT RUSH turnaround time is next day. COVID-19 ANTIBODIES test (blood work) is approximately 5 business days.



How will my test results be delivered?

Your test results are confidential and protected by HIPAA. We will call you with your results. If you require physical document showing your test result, let us know and we will email it to you.



Who can get tested for COVID-19 ANTIBODIES and/or COVID-19 PCR (nose swab) at Xera Med Research?

Xera Med Research services adults 18 years old and up.



What COVID-19 ANTIBODIES tests does Xera Med Research use?

Xera Med Research only uses the most reliable InBios for the ELISA test which has the FDA Emergency Use Authorization (EUA). There are several tests that received FDA EUA (such as Epitope’s kit NOT used by Xera) that have their EUA revoked for discrepancies in testing. Please keep this in mind should you choose to get tested at another lab. For more information on these tests and their manufacturers, please review their websites. The tests used by Xera Med Research are most sensitive and have shown to be most reliable.



I’ve heard on the news that antibodies tests at other labs are not accurate. What about Xera’s tests?

Xera Med Research uses the most reliable and sensitive tests available with accuracy rate of 99.8%. We do not make the test and we put our trust in the FDA’s review and guidelines for EUA. It is known globally that there are discrepancies even with FDA EUA tests – used by other laboratories and the sensitivity of the test can vary. Regardless, we are required to report all results to the DOH.



What is ELISA?

ELISA, enzyme-linked immunosorbent assay, is an analytical biochemistry assay. The assay uses a solid-phase enzyme immunoassay (EIA) to detect the presence of a ligand (commonly a protein) in a liquid sample using antibodies directed against the protein to be measured. ELISA has been used as a diagnostic tool in medicine, plant pathology, and biotechnology, as well as a quality control check in various industries.



Why does my lab report say SARS-CoV2?

The name of the virus is in fact SARS-CoC2 which is the same as COVID-19. Your lab report with show if you have either the IgM or IgG antibodies or both. For more virology information please contact your healthcare provider.



What is the COVID-19 ANTIBODIES test?

Antibody tests, a type of serological test, detect antibodies present in the blood when the body is responding to or has responded to a specific infection, such as COVID-19. Antibody tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself.



Is the COVID-19 antibody test used by Xera Med Research FDA approved?

Our test method platforms have received FDA Emergency Use Authorization (EUA). EUA does not mean FDA “approved” – FDA approval requires years of research, validation and numerous clinical trials.



Why is COVID-19 antibody testing important?

Testing individuals may help identify who has developed antibodies against SARS-CoV-2. The result of ongoing research are needed before it is know whether these antibodies are associated with protection from future infection. Current results can help inform who may qualify to donate blood that can be used to manufacture convalescent plasma, an investigational product for use with those who are seriously ill from COVID-19. The results can help determine how widely the virus has spread in our communities. You can read more on the importance of antibody testing in addressing COVID-19 here: https://discoverysedge.mayo.edu/2020/04/03/the-importance-of-antibody-testing-in-addressing-covid-19/



What's the big deal about antibodies?

For one, a serologic test can reveal whether a person might have developed immunity to COVID-19. Researchers haven't determined yet whether a person who has had and recovered from COVID-19 is protected from getting it again. But anecdotal evidence from China; preliminary studies in animal models; and experience from previous outbreaks, like severe acute respiratory syndrome and Middle East respiratory syndrome, suggest this might be the case. Having a serologic test may provide the opportunity to tell, for example, whether health care workers have developed immunity. Although such health care workers would still be required to wear personal protective equipment, they would be at lower risk for getting re-infected, compared to health care workers who do not have this immunity. A serologic test also might be used to determine the levels of COVID-19-related antibodies in a person's blood ― information that may be useful in the experimental treatment known as convalescent plasma therapy. Plasma is the component of the blood with no blood cells. The idea behind this treatment, which involves giving patients an infusion of antibody-rich plasma from those who have recently recovered, is that COVID-19 antibodies might neutralize the virus or jump-start a patient's own immune response. Researchers studying COVID-19 in China have suggested in two small case studies of patients that this pre-antibiotic era approach to treating infectious diseases might be a useful tactic in the pandemic. But studies of previous coronaviruses suggest that donors need to have high levels of antibodies in their blood for the therapy to work.



What is the COVID-19 PCR (nose swab) test?

COVID-19 PCR test is a nose swab test performed by collecting physical pieces of virus from the back of the nose. This test can detect if you currently have an active COVID-19 virus in your system.



About Your Test Result

My COVID-19 antibody test results came back negative, now what?

If your test results came back negative, please continue to protect yourself and others as per CDC recommendations.



My Antibodies Test results came back positive, now what?

If your test results come back positive for COVID-19 antibody (there are various stages of antibody response), please visit www.xeramed.com/book-now to schedule a visit at one of our locations and donate plasma for research for compensation. Time is of essence.



What does my COVID-19 antibody test results tell me?

Negative Result: no novel coronavirus antibody has been detected and the result is negative.
Positive Result, IgM only: the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
Positive Result, IgG only: the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
Positive Result, IgG and IgM: the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.



My COVID-19 antibody test came back positive for IgG or IgM, or both. What does that mean?

The test is capable of detecting both early marker and late marker, IgM/IgG antibodies in human blood, serum, and plasma samples. While nucleic acid PCR test is only positive during the brief window of acute infection, after which it becomes negative, the Elisa test administered by Xera Med Research is able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection. Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic.



What does it mean if I tested positive for IgM antibodies?

IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus. When IgM is detected you may still be infected, or you may have recently recovered from a COVID-19 infection.



What does it mean if I tested positive for IgG antibodies?

IgG antibodies develop in most patients within seven to 10 days after symptoms of COVID-19 begin. IgG antibodies remain in the blood after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past and have developed antibodies that may protect you from future infection. It is unknown at this point how much protection antibodies might provide against reinfection.



Can I help finding cure for COVID-19/Coronavirus?

Absolutely! If your COVID-19 test came back positive, be sure Visit www.XeraMed.com/book-now to set up a Plasma Donation appointment as soon as possible.



For more information on COVID-19 and antibody testing, please visit Infectious Diseases Society of America.

https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf