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


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Dec 3, 2017
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In ‘milestone,’ FDA OKs simple, accurate coronavirus test that could cost just $5 | Science | AAAS

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.
I wonder how soon they will be on the shelf at my local CVS or Walgreen.
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