COVID-19 Antibody Testing

Facts about COVID-19

  • The 2019 novel coronavirus disease (COVID-19) is a new virus of global health significance caused by infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • COVID-19 is thought to spread from person to person in close contact through respiratory droplets
  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It is also possible that a person can catch COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes
  • Currently, previous testing for COVID-19 has included a nasopharyngeal (NP) swab, which is tested for the presence of DNA from the virus. This is considered by the CDC to be the only way to confirm an active infection.
  • Please refer to the CDC for more information: https://www.cdc.gov/coronavirus/2019-ncov/lab/serology-testing.html.


Facts about the COVID-19 Panel

  • LabCorp has developed a novel test for COVID-19. The panel is a highly sensitive and accurate serum assay for viral antibodies.
  • The test was internally developed and validated according to FDA EUA requirements. The independent review of this validation by the FDA is pending. This test does not require confirmation by CDC prior to reporting results.
  • LabCorp’s COVID-19 panel looks specifically for IgM and IgG antibodies


Why Test Antibodies to COVID-19?

The serology test looks for the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood and in other tissues of those who are tested after infection. The antibodies detected by this test indicate that a person had an immune response to SARS-CoV-2, whether symptoms developed from infection or the infection was asymptomatic.

Antibody test results are important in detecting infections with few or no symptoms.

Currently, the test is designed for broad-based surveillance and research that will provide information needed to guide the response to the pandemic and protect the public’s health. The test is not currently designed to test individuals who want to know if they have been previously infected with COVID-19.

This test is not a substitute for a nasal swab test which is considered to be the best test to use during an active infection.

Please note:

  • The test is not currently designed to test individuals who want to know if they have been previously infected with COVID-19.
  • If you have current symptoms related to COVID-19 infection, please call your primary care provider. The CDC does not recommend antibody testing to diagnose COVID-19.
  • If you believe you have been exposed or developed symptoms, please consult your primary care provider. Please wait at least 2 weeks before having this test done.
  • There are currently no FDA-approved treatments for COVID-19. Our clinic does not claim to treat, cure or prevent COVID-19.

Steps to Get Tested

Step 1

Schedule your appointment.

Step 2

Come to our clinic and get your sample collected. Payment of $100 for the antibody test and a $60 office visit fee to cover the cost of phlebotomy, processing, clerical, etc. is required at the time of service. A receipt will be given for you to submit to your insurance company. Please check with your insurance company for potential reimbursement.

Step 3

Get results via a secure email in approximately 48 hours (depending on demand) after the lab receives your sample.

 

Regulatory Statement

The test has been validated but FDA’s independent review of this validation is pending. Negative 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 should be considered to rule out infection in these individuals. 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. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Not for the screening of donated blood.

The statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from healthcare practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act requires this notice.