A preliminary study has cast doubt on the efficacy of the Abbott device, which can provide results in minutes.
The agency said the Abbott ID NOW point-of-care test, which was given emergency authorization by the FDA in March, may return false negatives in some cases where patients actually have the coronavirus. The FDA said it had received 15 reports that the device didn’t reflect accurate results.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Tim Stenzel, director of the FDA’s office of in vitro diagnostics, said in a statement.“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test.
The agency noted it was sharing its concerns publicly “in the spirit of transparency,” clarifying that “no diagnostic test will be 100% accurate.”President Donald Trump opens a box containing a 5-minute test for COVID-19 from Abbott Laboratories on March 30. have been infected with the coronavirus and more than 85,000 have died.
The FDA stressed Thursday that any patient tested for COVID-19 who was given negative results but had ongoing symptoms consistent with the virus should have their results confirmed by another test. The Abbott device has been used at the White House to screen staff members and visitors and can provide rapid results. Trump himself trotted out the machine during a news conference, calling the results “But the White House has itself been rattled by the ongoing pandemic. Two staff members have tested positive for the virus in recent days — an
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