Healthcare Industry News:  COVID-19 

Diagnostics FDA

 News Release - February 3, 2021

New COVID-19 Antibody Test Receives Emergency Use Authorization by the FDA

DENVER, Feb. 3, 2021 -- (Healthcare Sales & Marketing Network) -- Scientists at the University of Denver have tested a new antibody test for COVID-19 that can predict if a patient will experience mild versus more severe symptoms of the virus. The revolutionary test has received an emergency use authorization from the U.S. Food & Drug Administration. The testing will be performed at Vibrant America Clinical Labs based in California.

FDA issues emergency use authorization for new COVID-19 antibody test that can predict severity of symptoms of the virus.

The University of Denver's Knoebel Institute for Healthy Aging collaborated with clinicians from Resilience Code, a Denver functional medicine and human performance clinic, and Vibrant Sciences LLC, a California-based company, to develop and study the test.

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

Using the new test, researchers discovered different antibody profiles between those who tested positive for COVID-19 and had severe symptoms versus those with milder symptoms.

"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," says Daniel Linseman, senior author of the research and associate executive director of the Knoebel Institute. "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."

"The flexibility of the semiconductor based multiplex platform enables testing for antibodies against multiple antigens," says Hari Krishnamurthy, director of biomedical engineering at Vibrant Sciences. "Originally developed to replace western blot testing for Lyme disease, we were able to rapidly reuse the technology to enable antibody testing for SARS-CoV-2".

The antibody test could be used to identify individuals who have been exposed to COVID-19 but have been asymptomatic. These individuals may have antibodies that could protect them from re-infection.

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

Researchers at the University of Denver are now using these findings to examine whether individuals with a history of severe concussions or other brain trauma are more susceptible to the virus and its long-term consequences.

About the University of Denver:

The University of Denver: Founded in 1864, the University of Denver is committed to engaging with students in advancing scholarly inquiry, cultivating critical and creative thought, and generating knowledge. The University strives to educate the 21st-century citizens and leaders needed in its organizations and communities. For additional information, visit the University's newsroom or follow the University on Facebook and Twitter.

Source: University of Denver

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