The FDA issued an alert warning the public that Abbott Laboratories’ rapid Covid-19 tests may deliver inaccurate results by rachsandl
The Food and Drug Administration issued an alert Thursday warning that Abbott Laboratories’ rapid COVID-19 tests may deliver inaccurate results, a major setback for the testing system commonly used around the U.S. as the country looks to ramp up its testing capacity.... [+]AP Photo/Carlos Osorio, FileThe FDA said it received 15 reports indicating Abbott’s ID NOW test produced false negative results, meaning that patients were told they were not infected when they actually had the disease.
The agency is investigating whether the false negatives were a result of the types of swabs used or the material used to transport the patient's specimen rather than a problem with Abbott’s machine.have raised questions about the test’s accuracy, including an NYU study released Wednesday, which hasn’t yet been peer reviewed, that found the company’s tests missed diagnosing up to half of known positive cases.
The test can still be used, the FDA said, but negative results may need to be confirmed with a separate molecular test.that Abbot is changing its instructions and telling healthcare providers to verify negative results with another test for patients with symptoms, possibly adding more time to the test that was lauded for producing results in under 15 minutes.
Abbott spokesman Scott Stoffel emphasized that only 15 inaccurate events were reported to the FDA out of the 1.8 million tests the company has shipped. He also pointed to additionalAbbott shares dropped 3.5% in after hours trading.“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue.
to NPR, causing the company change its instructions in April by telling users to not use the solution. Abbott’s tests are used by the White House to test members of the administration, including President Donald Trump himself.U.S. testing capacity has ramped up significantly since the early days of the outbreak. According to the COVID Tracking Project, the U.S. has averaged 345,000 tests per day since Monday, far more than this time last month. But public health experts say the U.S.
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