FDA Authorizes Use of UArizona COVID-19 Antibody Test; Testing Expanded to All Arizonans Age 18 and Older

Sept. 2, 2020
FDA Authorizes Use of UArizona COVID-19 Antibody Test; Testing Expanded to All Arizonans Age 18 and Older

 

TUCSON, Ariz. — The University of Arizona has received U.S. Food and Drug Administration authorization to use its COVID-19 antibody test, which was developed by a team of UArizona Health Sciences researchers. Since April, the university's test was able to be administered across the state while the FDA Emergency Use Authorization review process was underway.

Lab technician Gina Delgado registers blood samples before they are processed to determine if they show antibodies to the virus that causes COVID-19. (Photo: Kris Hanning/University of Arizona Health Sciences)The university and the state of Arizona also are expanding their COVID-19 antibody testing program to anyone in Arizona age 18 and older.

The antibody test determines who has been exposed to and developed an immune response against COVID-19. Information and registration for the test is available at covid19antibodytesting.arizona.edu.

“This antibody test developed by our own researchers is one of the most accurate tests in the country, with an estimated false-positive rate of less than 1 in 5,000,” said Michael D. Dake, MD, senior vice president for UArizona Health Sciences.

Combined with other tools, such as diagnostic testing and contact tracing, antibody tests can inform public health decisions about viral exposure, spread and protection.

“For coronaviruses that are most closely related to SARS-CoV2 – the virus that causes COVID-19 – antibodies continue to be produced for at least three years,” Dr. Dake said. “The structure of SARS-CoV2 contains no mutations that would suggest departure from this known behavior of coronaviruses. Based on this knowledge, immunity shorter than a year would be unprecedented for acute viral infections caused by this family of viruses, during which time a vaccine hopefully would become widely available.”

Differences in COVID-19 Testing

There are three types of tests being deployed during the pandemic. An antibody test uses a blood draw to determine whether an individual has developed an immune response after being exposed to COVID-19. The other two tests use nasal swabs to diagnose whether an individual is currently infected with the virus.

The UArizona Health Sciences COVID-19 Research webpage can be found here.

For the latest on the University of Arizona response to the novel coronavirus, visit the university's COVID-19 webpage.

For UANews coverage of COVID-19, visit https://news.arizona.edu/news/covid19.

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A version of this article appeared originally on the UANews website.

NOTE: Image and video available here https://arizona.box.com/s/okzpa56ws6g4hq5d6cu9v3cn9ij61tbt.

About the University of Arizona Health Sciences
The University of Arizona Health Sciences is the statewide leader in biomedical research and health professions training. UArizona Health Sciences includes the Colleges of Medicine (Tucson and Phoenix), Nursing, Pharmacy, and the Mel and Enid Zuckerman College of Public Health, with main campus locations in Tucson and the Phoenix Biomedical Campus in downtown Phoenix. From these vantage points, Health Sciences reaches across the state of Arizona, the greater Southwest and around the world to provide next-generation education, research and outreach. A major economic engine, Health Sciences employs nearly 5,000 people, has approximately 4,000 students and 900 faculty members, and garners $200 million in research grants and contracts annually. For more information: uahs.arizona.edu (Follow us: Facebook | Twitter | YouTube | LinkedIn | Instagram).

About the University of Arizona
The University of Arizona, a land-grant university with two independently accredited medical schools, is one of the nation's top public universities, according to U.S. News & World Report. Established in 1885, the university is widely recognized as a student-centric university and has been designated as a Hispanic Serving Institution by the U.S. Department of Education. The university ranked in the top 20 in 2018 in research expenditures among all public universities, according to the National Science Foundation, and is a leading Research 1 institution with $687 million in annual research expenditures. The university advances the frontiers of interdisciplinary scholarship and entrepreneurial partnerships as a member of the Association of American Universities, the 65 leading public and private research universities in the U.S. It benefits the state with an estimated economic impact of $4.1 billion annually. For more information: arizona.edu (Follow us: Facebook | Twitter | YouTube | LinkedIn | Instagram).