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Abbott Laboratories plans to ship tens of millions of antigen tests in September.

Abbott Laboratories

In ‘milestone,’ FDA OKs simple, accurate coronavirus test that could cost just $5

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

Coronavirus testing is set to get faster. Yesterday, the U.S. Food and Drug Administration (FDA) gave an emergency use authorization to Abbott Laboratories for a 15-minute test that should ease bottlenecks. Analogous to tests that detect HIV and influenza, the new diagnostic detects viral proteins, or antigens, that are unique to SARS-CoV-2, the virus that causes COVID-19. Unlike conventional coronavirus diagnostics, Abbott’s test requires no specialized laboratory equipment. Abbott says the new assay will cost $5, and the company intends to produce tens of millions of the tests in September and 50 million in October. By providing near–real-time answers on whether someone is infected, the novel test promises to let infected individuals quickly learn that they should isolate themselves and prevent further spread of the virus.

“This is wonderful news,” says Michael Mina, an epidemiologist at Harvard University’s T.H. Chan School of Public Health who has long called for a shift in testing priorities to antigen detection. “It will be administered first by physicians as a diagnostic, but this is a big step towards the development and approvals of similar assays that can eventually be used over the counter as public health tools. I am very excited about this milestone.”

Dubbed BinaxNOW, Abbott’s test uses a credit card–size device with a decades-old lateral flow technology to detect SARS-CoV-2 antigens. After a health care professional conducts a nasal swab of a patient, they insert the swab into the device along with a few drops of solution, which help the material flow across a strip containing antibodies that bind to the virus and create a color change to signal the presence of SARS-CoV-2 proteins.

Abbott’s device isn’t the first antigen test for SARS-CoV-2 on the market. But others require specialized equipment to read out results, limiting widespread use. Mina and other public health experts have repeatedly advocated for simpler antigen tests for use in schools and workplaces.

The United States currently conducts roughly 700,000 coronavirus tests per day. Nearly all of these assays require a centralized laboratory facility with specialized equipment to detect genetic material unique to SARS-CoV-2, making the cost of a typical test about $100. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results,” said Joseph Petrosino, chair of virology and microbiology at Baylor College of Medicine, in a statement released by Abbott. During that waiting period, patients often continue to interact with others.

Antigen tests can be much faster, but they are often less accurate. That doesn’t appear to be the case with the new Abbott design. According to FDA, the Abbott test correctly identifies patients with SARS-CoV-2 97.1% of the time and people without the virus 98.5% of the time.

If rolled out en masse, such simple, accurate assays could not only allow for faster patient testing, but also help relieve the backlog for beleaguered testing companies. “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,” said Charles Chiu, a laboratory medicine expert at the University of California, San Francisco, in a statement released by Abbott. That would help people get results faster even with older tests.

*Update, 28 August, 10 a.m.: The federal government announced on Thursday it has agreed to purchase 150 million rapid SARS-CoV-2 antigen tests from Abbott Laboratories.