Tags: Coronavirus | fda | hahn | abbott test | false negative | rapid test

FDA's Hahn: Rapid Virus Test Used at White House Being Evaluated

stephen hahn speaking in a suit and maroon striped tie as trump looks on
President Donald Trump listens to Commissioner of Food and Drugs Stephen Hahn. (Chip Somodevilla/Getty Images)

By    |   Friday, 15 May 2020 10:10 AM

As questions swirl about the accuracy of a coronavirus test that delivers results in minutes — a test used in the White House on President Donald Trump and others — the commissioner of Food and Drugs said the FDA still recommends that the test remain on the market.

Dr. Stephen Hahn was on "CBS This Morning" to discuss reports of false-negatives resulting from a rapid test developed by Abbott Laboratories.

"In this case, what we're saying is that there are some data to suggest that there may be inaccuracies, false-negatives, with the Abbott test," Hahn said. "However, there are many users who have contacted us and have not had this problem. So FDA is digging into it and we're working with Abbott to actually look at what data are available to get the most up-to-date and accurate information about the test performance.

"That being said, the test is on the market. We continue to recommend its use or to have it available for use."

When asked whether the FDA still recommends that the White House use the test, which Trump has touted several times, Hahn would not give a clear answer.

"We're providing guidance to the White House regarding this test," he said. "We have been on an ongoing basis. We will continue to do that, that will be a White House decision."

Hahn added, however, that if a doctor believes a patient might be sick with COVID-19 and he or she tests negative for the virus using the Abbott test, "it might be worth getting a second confirmatory test."

The FDA issued a statement Thursday that said the Abbott test has potential issues with accuracy after studies showed that false-negatives are occurring.

"We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health.

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As questions swirl about the accuracy of a coronavirus test that delivers results in minutes - a test used in the White House on President Donald Trump and others - the commissioner of Food and Drugs said the FDA still recommends that the test remain on the market. Dr....
fda, hahn, abbott test, false negative, rapid test
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2020-10-15
Friday, 15 May 2020 10:10 AM
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