The Food and Drug Administration has granted emergency use approval for Becton Dickinson's COVID-19 antigen test, the New Jersey company said Monday. The test can be used by people with little laboratory training on a portable device about the size of a smartphone that returns results within 15 minutes, Becton Dickinson said in a statement.
The tests can be run on the company's Veritor Plus System, which is already in use at about 25,000 U.S. health-care facilities, at a cost of about $20 per test, not counting the $250 to $300 price for the platform itself. "People keep saying 'For that, I want to buy one for my house,'" Becton Dickinson chief executive Tom Polen told Bloomberg News. (The FDA approved the test only for specific facilities, not home use.) In comparison, an antigen test by Quidel Corp. approved by the FDA in May can cost as little as $5 to administer, while Abbott Laboratories' rapid ID NOW system costs thousands of dollars.
Antigen tests are a relatively new form of diagnostic test that scan for proteins on or inside a virus, Reuters explains. Becton Dickinson suggested its test could be used in retail pharmacies, urgent care clinics, and doctor's offices, and set a goal of producing 2 million tests a week by the end of September. The downside of antigen tests is that they "may not detect all active infections," the FDA said in May. "This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection."
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