Additional tests may be required.
Becton Dickinson & Co. won a U.S. regulator’s approval for a portable Covid-19 test that delivers results in 15 minutes.
The Food and Drug Administration granted an emergency-use authorization for the BD Veritor Plus System, Franklin Lakes, New Jersey-based Becton Dickinson said Monday in a statement.
“It’s a breakthrough technology for the battle of Covid,” Becton Dickinson Chief Executive Officer Tom Polen said in an interview. The simplicity of the test design and procedure allows it to “be run in more routine settings, with less laboratory education and practice. It’s the most basic type of test people can run.”
The hand-held product, which is around the size of a mobile phone, is part of a new class of antigen testing technology that promises to bring faster, cheaper testing to doctors’ offices, urgent-care centers and other medical facilities.
Becton Dickinson’s new product runs on its Veritor Plus system, which is already used in more than 25,000 U.S. locations to detect strep throat and the flu. Manufacturing has already begun and shipping begins immediately. The company plans to produce up to 10 million tests by the end of September, and is working toward a capacity to manufacture 2 million a week.
The new antigen testing equipment is cheaper for medical facilities to buy and to use. Abbott Laboratories’ rapid ID NOW system, for instance, has a price tag in the thousands of dollars. Becton Dickinson’s Veritor Plus System has an average selling price of $250 to $300, and the tests themselves are about $20 each, Polen said.
Questions about accuracy have dogged even the diagnostic tests that are considered the gold standard for Covid-19. They also arise with antigen tests. In clinical studies, Becton Dickinson’s product was able to reach about 84% sensitivity, which measures the rate of true positive results, according to the company statement on Monday. It also reached 100% specificity, which describes the rate of true negatives.
Antigen tests “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.”
The results may also require another diagnostic test “prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative,” the FDA said.