FDA gives emergency approval to rapid, cheap coronavirus antigen test

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.

A patient is given a nasal swab, which is then inserted into the test card. The test is designed to look for small proteins on the surface of the coronavirus, according to an approval letter from the FDA. If such proteins are present in the sample, the test, known as the “BinaxNOW COVID-19 Ag Card,” will display a colored line to indicate a COVID-19 infection.

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.

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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.

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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.

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