FDA warns of deficiencies of one of the rapid tests administered in the United States

FDA Warns Of Deficiencies Of One Of The Rapid Tests Administered In The United States

Washington, D.C. – The director of the United States Food and Drug Administration (FDA) said Friday that his agency has provided new guidelines to the White House in response to new information that a rapid test for COVID-19 used by President Donald Trump and others every day can provide inaccuracies and false negative results.

Commissioner Steve Hahn said that if a person is suspected of being infected with the disease caused by the coronavirus, “it would be worth it, if the test is negative, to get a second confirmatory test. That is what our guidelines are about. “

The Abbott Laboratories test is used every day at the White House to screen Trump and crucial members of his staff, including the coronavirus response task force. The FDA said Thursday night that it was investigating preliminary data hinting that the 15-minute test may overlook cases of COVID-19 by failing to detect infected people.


When asked on CBS on Friday if he would continue to recommend the use of the test in the White House, Hahn replied, “That will be a decision of the White House.” But he noted that the test is on the market and the FDA continues to “recommend its use or make it available for use.”

Federal health authorities have alerted doctors to the possible inaccuracy in the test, which is used in thousands of hospitals, clinics, and test sites across the United States.

The FDA warning came a day after New York University researchers reported that according to the results, the Abbott test may miss half of the infections detected by a rival test made by Cepheid. The research has not been peer-reviewed or published in a medical journal and was based on approximately 100 patients.

The researchers found that the Abbott test, performed on the company’s NOW portable identification system, missed a third of the infections that the Cepheid test detected when the swabs were stored in liquid used to transport laboratory samples. When the samples were kept dry, the test did not detect 48% of the cases revealed by Cepheid.

The researchers said the test result was “unacceptable,” due to the risk of mistakenly ruling out patients who could spread the infection to others. They recognized the shortcomings of the study, including the time it took to transport patient samples to the device for processing.



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