FDA gives emergency approval to rapid, cheap coronavirus antigen test

News
By published

Abbott Lab's rapid antigen test can be run without lab equipment in 15 minutes.

Abbott's rapid coronavirus test is the size of a credit card.
Abbott's rapid coronavirus test is the size of a credit card. (Image credit: Abbott Labs)

The U.S. Food and Drug Administration has authorized a new, rapid antigen test for COVID-19, which costs $5 and can diagnose an infection in 15 minutes.

The test, made by Abbott Labs, is the size of a credit card and does not require any lab equipment to run. Rather, the device has a similar design to some pregnancy tests, allowing health care providers to read test results directly from the testing card, the FDA said.

The test has demonstrated 97.1% sensitivity and 98.5% specificity, according to Abbott. When a test is sensitive, it means that it correctly diagnoses most people who are infected with the virus; whereas when a test is specific, it means it doesn't have many "false positives," according to a previous Live Science report.

The rapid test also comes linked to an app called NAVICA, which will allow users that test negative to display their results to organizations as a "digital health pass," according to a statement released by Abbott.

"With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results," Joseph Petrosino, a chairman and professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas said in the Abbott statement. Petrosino’s labs have been leading efforts to provide testing for Baylor College and Harris County in Texas, according to the statement. "With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus,” Petrosino said. But the test is only allowed to be given by healthcare professionals.

The new test is the fourth antigen test to receive "emergency use authorization" (EUA) from the FDA , according to CNN. Emergency use authorization is permission given to unapproved products to be used in an emergency to diagnose, treat or prevent serious or life-threatening conditions, "when there are no adequate, approved, and available alternatives," according to the FDA.  

By the beginning of October, Abbott will ship out about 50 million tests a month, according to the statement.

Originally published on Live Science.

Yasemin Saplakoglu
Yasemin Saplakoglu
Staff Writer

Yasemin is a staff writer at Live Science, covering health, neuroscience and biology. Her work has appeared in Scientific American, Science and the San Jose Mercury News. She has a bachelor's degree in biomedical engineering from the University of Connecticut and a graduate certificate in science communication from the University of California, Santa Cruz.