Federal health officials in the United States are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the White House.
The Food and Drug Administration said late Thursday it is investigating preliminary data suggesting Abbott Laboratories' 15-minute test can miss COVID-19 cases, falsely clearing patients of infection. The test is used daily at the White House to test President Donald Trump and key members of his staff, including the coronavirus task force.
Abbott rejected the findings, saying the researchers used the test "in ways that it was not designed to be used." The FDA said in a statement it is reviewing the data with Abbott and working on a letter to health care providers about potential accuracy issues. The agency said physicians may need to confirm the results of a negative Abbott test if patients have signs and symptoms of the virus. Regulators said they are requiring Abbott to conduct follow-up studies on the test's accuracy.
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