Sept. 2, 2020
FDA Authorizes Use of UArizona COVID-19 Antibody Test; Statewide Antibody Testing Expanded to Anyone in Arizona 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.
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 Dr. Michael D. Dake, 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," 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.
Media contact:
Gerri Kelly
University of Arizona Health Sciences
602-827-3036
gkelly@arizona.edu
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 the latest on the University of Arizona response to the novel coronavirus, visit the university's COVID-19 webpage.