The U.S. Food and Drug Administration (FDA) on Monday authorized two special new COVID-19 tests that could not only tell people if they have ever contracted the virus, but also estimate how many viral antibodies there are in the body,media reported. This is the latest iteration of the so-called serological test, which is not intended to determine whether a patient is currently infected with COVID-19, but to determine whether a patient has ever contracted a new coronavirus and then grant an individual an immunity to it in the future.
The testing of COVID-19 has been controversial since the outbreak began. In addition to the focus on getting tests — which remains a divisive topic, especially in the United States, where access to new coronavirus testing is still difficult or too expensive — there are several types of testing that can be performed.
PCR or antigen testing is used to determine whether a person is currently infected with COVID-19. However, they do not show whether a person has been infected in the past, but has since recovered. For this reason, serological testing has been used;
Now, the FDA has licensed two new serological tests that can show an estimate of the number of antibodies in an individual’s blood, rather than simply confirming their presence. ADVIA Centaur COV2G and Atellica IM COV2G can show the number of antibodies produced against the COVID-19 virus.
“Being able to measure patients’ relative antibody levels for previous SARS-CoV-2 infections may be useful as we continue to learn more about the virus and what the presence of antibodies may mean,” said Dr. Tim Stenzel, Director of the Office of In vitro Diagnostics and Radiology Health at the Center for DA Equipment and Radiological Health, explaining the newly authorized diagnostic method. “The presence of SARS-CoV-2 antibodies may tell us about potential immunity, and there are still many unknowns, but today’s authorization gives us additional tools to evaluate these antibodies as we continue to study and study the virus.”
One of the confusing factors in developing treatment and management strategies for COVID-19 is understanding how antibody responses work. For example, it is not clear how long these antibodies last in the body after infection. Even if they do exist, scientists aren’t sure whether they will prevent future reinfection.
“Patients should not interpret the results as telling them they are immune, ” Dr. Stenzel cautions, “or there is any level of immunity.” The FDA says that while antibodies to the new coronavirus may be identified, it does not mean that a person can safely return to work. The Centers for Disease Control and Prevention (CDC) changed its guidelines for COVID-19 isolation and return to work at the end of July.