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Research has suggested that the Abbott ID NOW point-of-care test may return false-negative results.

FDA: Abbott Rapid COVID-19 Test Could Miss Infections

FRIDAY, May 15, 2020 (HealthDay News) -- A rapid COVID-19 test being used across the United States could miss infections, the U.S. Food and Drug Administration said Thursday.

Some scientific studies have suggested that the Abbott ID NOW point-of-care test may return false-negative results, and the FDA has received 15 reports about the device that suggest it failed to diagnose COVID-19 infections, the agency said.

"We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," Tim Stenzel, M.D., director of the Office of In Vitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health, said in an FDA news release. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test."

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