The IMMUNO-COV test detects antibodies that can recognize and block the virus that causes COVID-19. Antibodies are part of your body’s natural immune defenses. They recognize threats, such as viruses and bacteria, and alert your immune system to destroy them. If your body produces an antibody that (1) binds to and blocks the virus or bacteria’s receptor from binding to new cells, and (2) enough antibody to surround the threat, it can prevent the virus or bacteria from infecting new cells (neutralization).
Patients who have recovered from COVID-19 continue to produce antibodies that bind the SARS-CoV-2 spike protein. The IMMUNO-COV test detects antibodies in your blood that can recognize and stop a mimic virus from infecting new cells. These antibodies are detectable in the blood typically 14 days after the onset of infection.
A Different Type of Antibody Test
IMMUNO-COV tells you whether you have neutralizing antibodies, antibodies that can block the COVID-19 virus from infecting cells. Other antibody tests, such as ELISAs or Point of Care tests, can also detect the antibodies that recognize the COVID-19 virus. However, these tests cannot tell you how effective these antibodies are at blocking the virus from infecting cells.
Getting the Test
You can only get an IMMUNO-COV test from your healthcare provider. A small sample of your blood will be sent to a lab where the test is done. Your healthcare provider will normally have the result of your test back within 3 working days.
How the Test Works
The COVID-19 virus is covered in ‘spike’ proteins, which allow the virus to attach to and infect human cells. The IMMUNO-COV test uses a harmless virus that mimics SARS-CoV-2 by having the same spike proteins on its surface. Specially engineered test cells are designed to glow if they are infected by the mimic virus. The IMMUNO-COV test measures how effective your antibodies are at blocking the mimic virus from infecting test cells in the lab. This result tells if you have neutralizing antibodies against the COVID-19 virus.
If you have a positive test result (antibodies that block the virus are present), the cells do not glow. If you have a negative test result, there are no protective antibodies so the cells glow brightly.
IMMUNO-COV and FDA approval
IMMUNO-COV has been independently validated by Vyriad, and is offered as a Lab Developed Test. This test was validated using serum from more than 230 individuals. The test procedure and validation are currently being reviewed by the U.S. Food and Drug Administration for an Emergency Use Authorization.
Questions & Answers
How accurate is IMMUNO-COV?
In tests so far, IMMUNO-COV has shown 100% agreement with people who tested positive for COVID-19 antibodies by ELISA (another type of serology test), and zero false positives have been detected in people known to be negative for COVID-19. There is a small chance that IMMUNO-COV could give a false result.
Can I have a positive test result and not have COVID-19 immunity?
We are still studying if neutralizing antibodies detected by IMMUNO-COV can protect from new infection with the COVID-19 virus. Updates about this will be provided as researchers uncover new information.
If my test is positive, can I go back to work or school?
We do not know yet whether having COVID-19 immunity will prevent you from infecting others. We suggest that you follow the US Government guidelines on how and when you can return to work or school. Your healthcare provider can provide you with the guidelines.
If my test is positive, can I visit older people and those with underlying health problems?
We do not know yet whether having COVID-19 immunity will prevent you from infecting others. We suggest that you follow the US government guidelines on how and when you can visit others. Your healthcare provider can provide you with the guidelines.
How long does COVID-19 immunity last?
We do not yet know how long COVID-19 immunity lasts. We know that people who are infected with other coronaviruses, such as MERS virus or SARS virus, are unlikely to be re-infected soon after recovering. However, we do not know whether we will see similar immunity against the COVID-19 virus.
Who makes the IMMUNO-COV test?
IMMUNO-COV has been developed by Vyriad, a biotechnology company based in Rochester, Minnesota, with support from Imanis Life Sciences (Rochester, Minnesota) and in collaboration with Regeneron Pharmaceuticals (Tarrytown, New York) and Mayo Clinic (Rochester, Minnesota).
Who pays for an IMMUNO-COV test?
You should check this with your insurance provider.