U.S. regulator is reviewing Abbott’s fast COVID test after studies raise accuracy concerns

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(Reuters) – The U.S. Food and Drug Administration said on Thursday that Abbott Laboratories’ (ABT.N) speedy coronavirus test, which can deliver results within minutes and is used at the White House, could potentially be inaccurate but can still be used to test patients.

FILE PHOTO: An Abbott company logo is pictured at the reception of its office in Mumbai, India, September 8, 2015. REUTERS/Shailesh Andrade

The regulator said in a statement that early data about the Abbott ID Now test suggested it could produce potentially inaccurate results, particularly by failing to detect people who have the illness.

It

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FDA tightens rules on coronavirus antibody tests after accuracy concerns

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A Detroit resident is tested for free for the coronavirus disease (COVID-19) and antibodies at the Sheffield Center in Detroit, Michigan, April 28, 2020.

Rebecca Cook | Reuters

The Food and Drug Administration on Monday tightened rules for coronavirus antibody tests, ordering manufacturers to submit emergency use authorization forms and data proving the tests work within 10 days or face possible removal. 

So-called serological, or antibody, tests can indicate whether a person has had Covid-19 in the past and was either asymptomatic or recovered.

So far, 12 antibody tests have been authorized by the FDA for emergency use, and more

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Dr. Scott Gottlieb says he would take three antibody tests to ensure accuracy

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Dr. Scott Gottlieb on Monday warned about the accuracy of antibody tests for the coronavirus, telling CNBC that people should not trust the results of only one test. 

“If you do go out and get an antibody test, and you get a positive result, meaning you have the antibodies, I would suggest you repeat it,” the former head of the Food and Drug Administration said on “Squawk Box.” 

Gottlieb said the tests have a high false positive rate, making it difficult to know whether a single result is credible. He said the likely accuracy of the test increases if the

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Accuracy of antibody testing questioned, Russia faces huge challenge

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This is CNBC’s live blog covering all the latest news on the coronavirus outbreak. All times below are in Eastern time. This blog will be updated throughout the day as the news breaks. 

  • Global cases: More than 2.5 million
  • Global deaths: At least 178,371
  • US cases: More than 825,300
  • US deaths: At least 45,075

The data above was compiled by Johns Hopkins University.

7:48 am: Most antibody tests will ‘give a very high false positive rate’

Serology tests, which can detect the presence of coronavirus antibodies and identify whether someone has already been exposed to Covid-19, have a “very

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