FDA: Abbott Rapid COVID-19 Test Could Miss Infections
Research has suggested that the Abbott ID NOW point-of-care test may return false-negative results
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."
A study released this week by NYU Langone Health researchers concluded that the Abbott ID NOW test could miss COVID-19 infections up to 48 percent of the time. The study has not been peer-reviewed. The test is designed to be used in physician offices and clinics and is being used in drive-through testing sites nationwide and also at the White House to test staff. In a statement, Abbott said its reported rate of missed infections with the test was 0.02 percent and that the NYU Langone findings were "not consistent with other studies of the test," The New York Times reported.