Abbott’s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable and affordable tool for detecting active coronavirus infections at massive scale, said the company. Courtesy photo of Abbott Laboratories

SCARBOROUGH — Chicago-based company Abbott Laboratories, which has a location in Scarborough, announced that the FDA has issued Emergency Use Authorization for a $5, 15-minute mobile Covid-19 test.

On Aug. 26, the company said that the test kit, BinaxNOW COVID-19 Ag Card is about the size of a credit card, and comes with a complementary app that is the first of its kind.

“BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their health care provider,” Abbott said. “With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.”

Abbott will ship tens of millions of these testing kits in September and 50 million in October, the company said.

The tests have demonstrated sensitivity of 97.1 percent and specificity of 98.5 percent, Abbott said.

Tens of millions of people will be able to get rapid and reliable testing because of the massive scale of the test and app, said Joseph Petrosino, professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine.

“With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results,” he said. “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.”

Abbott said that BinaxNOW was engineered for point-of-care settings, near-patient, not for reference labs. The samples need to be tested immediately.

“If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass,” Abbott said. “If test results are positive, people receive a message to quarantine and talk to their doctor.”

The BinaxNOW test could be used as a first line of defense against COVID-19, identifying the infected quickly so they may isolate themselves from others, Abbott said.

Charles Chiu, professor of Laboratory Medicine at University of California, San Francisco, said that the United States’ frontline health care workers and clinical laboratory personnel have been “under siege” since the COVID-19 pandemic began.

“The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it,” he said.

The company said that it has invested millions of dollars in two new U.S. facilities to manufacture the tests at a rapid scale.

Abbott Diagnostics, part of Abbott Laboratories, recently purchased its 10 Southgate Road, Scarborough location for $16.95 million, according to an article in Mainebiz. The company had been leasing the property for the past several years.