COVID-19 Rapid Antibody Testing in NYC

We at Center For Spine Care and Mobility (CSC+M) know how important it is to see if you had contracted COVID-19. On March 16, 2020 the FDA updated its policy for diagnostic tests for Coronavirus Disease-2019 during the public health emergency. The updates include guidance that allows for serological tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 for clinical specimens, like Phamatech COVID-19 IgG/IgM Rapid Test, to be used in laboratories or by healthcare workers.

Many people are curious to find out whether they contracted COVID. While that is important for multiple reasons, including having the ability to donate plasma that may save someone’s life, it’s also extremely important to find out if you have IgM antibodies. Immunoglobulin M (IgM): Found mainly in blood and lymph fluid, this is the first antibody the body makes when it fights a new infection. Immunoglobulin G (IgG): This is the most common antibody. It’s in blood and other body fluids, and protects against bacterial and viral infections. IgG can take time to form after an infection or immunization.

Many people are walking around asymptomatic but still showing IgM antibodies. This means they can still be contagious and can spread the virus to people they come into contact with.

We researched and tested different COVID-19 tests and found a company that offers a simple test with research to back it up. This IGG/IgM Rapid Test is manufactured in the US in an FDA certified lab. It has been FDA reviewed and registered with the FDA. The test is completed by a simple finger prick and results will be ready in 15 minutes. Its accuracy to the antibodies IgG is 98% and IgM 93%. Current testing statistics reveal around 5-6% of the people who test are positive for antibodies. Antibodies inform us you have previously contracted the virus and your body has made antibodies to fight it. The research supports once you have the antibodies, you cannot get this strain again. However, we do not know this with 100% certainty at this point. Until there is more research, no one will know for sure.

This test looks for antibodies that tell us if you HAD COVID-19. It is not meant to tell us if you currently HAVE the virus and therefore should not be the sole criteria in determining whether you may have the virus or not. That can only be done by a swab test, which we are not offering. If you are sick and have symptoms, we are recommending that you should consult your primary care physician or visit a swab testing site.

Please note the following information.

Intended Use

Pharmatech COVID-19 IgG/IgM Rapid Test Card is intended to be used in conjunction with other tests and/or clinical and epidemiological information:

1. For the in vitro qualitative detection of IgM and IgG antibodies specific to SARS-CoV-2 (detected in China in 2019) in whole blood / serum / plasma collected directly from symptomatic patients. The test may cross react with other viruses not tested for.
2. For the presumptive identification of viral infections in patients who may be infected with SARS-CoV-2 in conjunction with clinical and epidemiological risk factors. The test may cross react with other viruses not tested for.
3. To provide epidemiological information for surveillance of SARS-CoV-2.

All test results are presumptive and should be confirmed by an approved molecular assay. A presumptive negative test does not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, a presumptive positive result does not rule out infections caused by other viruses.

Limitations

1. Pharmatech COVID-19 IgG/IgM Rapid Test Card is for in vitro diagnostic use only. This test should be used for detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimens. Neither quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to COVID-19 can be determined by this qualitative test.
2. Pharmatech COVID-19 IgG/IgM Rapid Test Card will only indicate the presence of IgG and IgM antibodies to COVID-19 in the specimen and should not be used as the sole criteria for the diagnosis of COVID-19 infections.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of COVID-19 infection.
5. The hematocrit level of whole blood can affect the test results.
6. The test will show negative results under the following conditions: The titer of the novel Coronavirus antibodies in the sample is lower than the minimum detection limit of the test, or the novel Coronavirus antibody has not appeared at the time of sample collection (Asymptomatic stage).
7. Negative test results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic (swab test) should be considered to rule out infection in these individuals.
8. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
9. Positive results may be due to past or present infection with non-SARS-CoV-2 Coronavirus strains, such as Coronavirus HKUI, NL63, OC43, or 229E.

How to Get Tested

You may call or email our office with your request to have the COVID-19 antibody test administered. We will block out a 15 minute window for you to receive the test as well as get your results. As states above the test consists of a small finger prick and a draw of two droplets of blood. That’s really it. The cost of this test is $45.

Please let us know if you have any questions.

Regards,
Dr. Anselmi and the team at Center For Spine Care and Mobility