FDA approvals

August 27, 2020

FDA Approves New Rapid COVID-19 Diagnostic Test

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THURSDAY, Aug. 27, 2020 -- The first rapid COVID-19 test that does not need any special computer equipment to produce results was approved by the U.S. Food and Drug Administration on Wednesday.

Made by Abbott Laboratories, the 15-minute test will sell for $5, giving it an edge over similar tests that need to be inserted into a small machine, the Associated Press reported. No larger than a credit card, the Abbott test is based on the same technology used to test for the flu, strep throat, and other infections. BinaxNOW is the fourth rapid test in the United States that detects COVID-19 antigens rather than the virus itself. It is considered a faster, but less precise, screening method.

Abbott's entry into the rapid COVID-19 test market offers yet another option to expand testing. The FDA also recently approved a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks, the AP reported. Neither test can be performed at home. Abbott's new test still requires a nasal swab be taken by a health care worker, like most older COVID-19 tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories. Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening. While considered highly accurate, the tests rely on expensive, specialized machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, the wire service said.

Roughly 690,000 Americans are now being tested per day, down from a peak of 850,000 daily tests late last month, the AP reported. But many public health experts believe the country will soon need to test vastly more people as schools reopen and the flu season arrives.

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