COVI-QUANT™: COVID-19 quantitative antibody test

Because not everyone develops a strong immune response after COVID-19 infection or vaccination

Do you know your COVID-19 antibody level?

The COVI-QUANT™ test will give you an answer. It represents the latest generation of testing technology that will provide a numerical value for your antibody level, not just yes or no. COVI-QUANT™ is an ELISA test available through Kephera’s CLIA laboratory.

Studies show that not all individuals develop a strong immune response after COVID-19 infection or vaccination, especially those who have an immunocompromising condition due to disease, medical treatment, organ transplantation, age, or other causes.  These individuals may continue to be at risk of COVID-19 infection due to a weak immune response, which can be reflected in low antibody levels.

Additionally, how long COVID-19 vaccines will protect even healthy people is unknown at this point.  Monitoring antibody levels over a period of months or years can provide a way to gauge the strength of the immune response as it changes.

I know that people respond differently to the vaccine – how do my antibody levels compare to the rest of the vaccinated population?

I am immunocompromised and I want to check whether I mounted an immune response to the vaccine.

How have my antibody levels changed over the months since my vaccination?

I need evidence that I was vaccinated and have antibodies to be able to travel.

How does it Work?

The COVI-QUANT™ test detects antibodies to the Spike protein - the major component of all COVID-19 vaccines

The COVI-QUANT™ test is an Enzyme-Linked Immunosorbent Assay (ELISA) that detects antibodies against the spike protein, which is a major feature of the SARS-CoV-2 virus and the main component in all COVID-19 vaccines.  Many other antibody tests on the market target proteins that may not be used in vaccines.

The COVI-QUANT™ test measures antibody levels in WHO international standard units

Kephera’s COVI-QUANT™ test is a quantitative test that measures the level of antibody in your blood after COVID-19 infection or vaccination. The COVI-QUANT™ test yields a numerical value for your antibody level. This differs from other antibody tests that may only provide you with a positive/negative result.

Kephera’s  COVI-QUANT™ test is calibrated to the  World Health Organization (WHO) standard1.  You will receive your COVI-QUANT™ results in Binding Antibody Units (BAU/ml),  the international standard established by the WHO.

  1. Kristiansen, P. A. et al. WHO International Standard for anti-SARS-CoV-2 immunoglobulin. The Lancet 397, 1347–1348 (2021).

Antibody levels vary across people: The COVI-QUANT™ test allows you to compare your level to others

Most people will develop antibodies within several weeks after receiving a COVID-19 vaccine or after being infected with the virus.  The strength of your immune response to vaccination or infection is determined by many factors including your age, health, and pre-existing conditions2,3,4.

The COVI-QUANT™ test will tell you your antibody level, and how it compares with the levels of others who have been vaccinated or infected. The graph shows antibody levels measured using COVI-QUANT™ in vaccinated and infected individuals, and highlights the variability in levels between individuals and between the two groups.  Some infected or vaccinated people show very low or undetectable levels of antibodies.

Higher levels of antibody reflect a stronger immune response, and vice-versa.  The exact relationship between antibody levels and degree of immunity to COVID-19 infection is still being researched.

  1. Anderson, E. J. et al. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N. Engl. J. Med. 383, 2427–2438 (2020).
  2. Eberhardt, C. S., Balletto, E., Cornberg, M. & Mikulska, M. Coronavirus disease 2019 vaccination in transplant recipients. Curr. Opin. Infect. Dis. (2021). doi:10.1097/QCO.0000000000000739
  3. Widge, A. T. et al. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. https://doi.org/10.1056/NEJMc2032195 (2020).

Antibody levels can rise or fall: The COVI-QUANT™ test allows you to track your level over time

It is not yet clear how long antibodies continue to circulate in people who have been vaccinated or infected, and how long vaccine immunity lasts.  Some studies show that antibody levels after vaccination or infection decrease over time5,6.

The graph shows the change in antibody levels measured by COVI-QUANT™ in an individual who was tested at successive time points after COVID-19 vaccination.

Tracking changes in your immune response over the months that follow vaccination or infection can assist you and your healthcare provider in evaluating your ongoing COVID-19 infection risk.

  1. Widge, A. T. et al. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. https://doi.org/10.1056/NEJMc2032195 (2020).
  2. Dan, J. M. et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science (80-. ). 371, (2021).

Antibody levels measured with the COVI-QUANT™ test correlate with neutralization activity

Antibodies typically protect you from infection.  Neutralization refers to the ability of antibodies to block the binding of the SARS-CoV-2 virus to the human receptor, and neutralization activity is associated with protection7.   It is not yet known what level of antibodies is needed to protect an individual from COVID-19 infection, but higher levels are likely to confer greater protection and vice-versa.

The COVI-QUANTTM test shows strong agreement with an FDA-approved neutralization test. Samples with low antibody levels as measured by the COVI-QUANT™ test showed low levels of neutralization, while samples with high levels of antibodies showed high neutralization activity.

  1. Khoury, D. S. et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat. Med. 1–7 (2021). doi:10.1038/s41591-021-01377-8

Example of Test Report

A Test Report will be sent to the patient and physician within 3 days after the sample is received by Kephera’s laboratory

Get Started with Your Test

Get Provider Approval

Collect & Ship Blood Sample

Get Results in 1-3 Days

Group Tests

For group testing or to schedule a clinic at your company site, please contact Kephera sales at 774-777-3558.

    Frequently Asked Questions:

    Why should I get a COVI-QUANT™ test?

    • The COVI-QUANT™ test can measure the level of antibodies in response to vaccination with a COVID-19 vaccine.
    • The COVI-QUANT™ test can measure the level of antibodies to SARS-CoV-2 resulting from a COVID-19 infection.

    Should I get tested?

    This test may be right for you if you:

    • Have received a COVID-19 vaccine or
    • Had or suspect you have had COVID-19 in the past and
    • Have not experienced symptoms consistent with COVID-19 in the past 14 days; please check COVID-19 symptoms information on the CDC website.

    When should I get tested?

    • It is recommended to get tested at least two weeks after vaccination, or after symptoms of active infection have disappeared. That amount of time is needed for the antibodies to be formed in response to the vaccine or the virus.

    This test is NOT right for you if you:

    • Have been diagnosed with COVID-19 or were directly exposed to the virus in the past 14 days.
    • Have experienced symptoms consistent with COVID-19 in the past 14 days.
    • Are feeling sick or have had a fever within the last 24 hours.

    What does the test result tell you?

    • If you have been vaccinated for COVID-19, the COVI-QUANT™ test will measure your IgG antibody level to the major vaccine component.  You can compare your IgG level with the levels in people in your demographic group who have also been vaccinated (web tool coming soon).
    • If you were previously infected with COVID-19, the COVI-QUANT™ test will measure your IgG antibody level. You can compare your level with the levels in people in your demographic group who have also been infected (web tool coming soon).
    • The COVI-QUANT™ test will allow you to monitor your level of IgG antibody to the major vaccine component over time, and to detect any significant change in antibody level.  An increase in antibody level suggests that your immune response to COVID-19 is rising.  A decrease in antibody level suggests that your immune response to COVID-19 is falling, and you may wish to consult your physician about how to reduce your risk of infection.

    Do I have immunity to COVID-19 if I have measurable antibodies to the vaccine or the virus?

    • The presence of antibodies to the SARS-CoV-2 virus , may provide protection against COVID-19. Scientists are studying the relationship between antibody level and immunity to the SARS-CoV-2 virus, but the exact level of antibody that confers immunity is not yet known.

    I may be immunocompromised – can I still get tested with the COVI-QUANT™ test?

    • Yes, you can get tested with the COVI-QUANT™ test, and the results will provide you with your level of IgG antibody to the major vaccine component. You can compare your IgG level with the levels in people in your demographic group who have also been vaccinated (web tool coming soon). We recommend discussing all results with your health care provider.

    How should I prepare for the COVI-QUANT™ COVID-19 antibody test?

    • Consult your doctor, who will need to provide you a prescription for the test, sign the test requisition form and arrange for a blood draw.

    What is the procedure for the COVI-QUANT™ COVID-19 antibody test?

    • Your health care provider will approve the test and sign the test requisition
    • You will have your blood drawn by a health care professional, by venipuncture (a blood sample will be taken from a vein in your arm).
    • The sample will be sent to our lab for testing.
    • We will run our COVI-QUANT™ test on your blood sample to measure the level of antibodies against the major COVID-19 vaccine component.
    • You will receive the test result within 72 hours.
    • More details on Test Ordering Instructions can be found here.

    How can I get a doctor’s prescription?

    • Print our test requisition form and contact a licensed physician (MD, DO, NP, PA, or ND). Bring your test requisition with you for the physician or other healthcare provider to fill out.
    • Alternatively, email your test requisition form to your PCP, and request them to fill it out.

    Kephera Diagnostics is a CLIA (Clinical Laboratory Improvement Amendments) licensed laboratory that excels in moderate and high-complexity diagnostic testing. Our dedicated team of scientists are experts in the field of infectious diseases. Through innovative research and collaboration with public health institutions and medical researchers Kephera Diagnostics provides vital testing for patients and healthcare providers. Kephera Diagnostics is HIPAA compliant.

    Contact us today with any questions.