FDA Grants Emergency Use Authorization to New COVID-19 Antibody Test

The United States Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to a novel coronavirus disease 2019 (COVID-19) antibody test that is able to determine the severity of an individual’s symptoms.

The test was developed by Vibrant American Clinical Labs, a leading science and technology company, and tested by investigators from the University of Denver’s Knoebel Institute for Healthy Aging and Resilience Code, a functional medicine and human performance clinic.

“This antibody test has more test points than others that have been approved by the FDA,” Lotta Granholm-Bentley, the founding executive director of the Knoebel Institute and one of the project’s lead researchers said. “Other tests check for only a few viral antigens, whereas this one could test for as many as a dozen.”

Investigators discovered different profiles of antibodies between people who were positive with the virus and had mild or severe symptoms. Using this information from the test, they were able to predict the severity of their outcome.

“We also discovered that individuals who have been vaccinated for the flu in the past year exhibited more mild symptoms than those who had not,” Daniel Linseman, senior author of the research and associate executive director of the Knoebel Institute said. “We found that individuals who experienced the loss of taste or smell also tested positive for COVID antibodies, making this symptom an important aspect of reporting in the clinic.”

Additional findings suggest that the test may also be able to identify those who have been exposed to the disease but have so far been asymptomatic.

“This breakthrough has the ability to give doctors a head start on treatment and speed up the process of diagnosing patients,” Jeremy Haefner, chancellor of the University of Denver said. “I’m proud of this achievement by DU scientists and their collaboration with other researchers to make this important discovery.”