May 15, 2020 - Health

FDA: Abbott coronavirus test may falsely tell patients they don't have the virus

In this image, Trump holds the coronavirus test at the White House

President Trump holds the Abbott Labs coronavirus test at the White House on March 30. Photo: Win McNamee/Getty Images

The FDA has received at least 15 reports that suggest Abbott Labs coronavirus tests are inaccurately telling patients that they do not have the virus, FDA said in a Thursday press release citing early data.

Why it matters: These tests have been widely distributed by the federal government in response to the pandemic. The U.S. deployed over 235,000 tests to public health laboratories in every state across the U.S., Assistant Secretary of Health Adm. Brett Giroir said on Monday.

What they're saying: "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test," Tim Stenzel of the FDA's Center for Devices and Radiological Health 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," he said.
  • Specifically, the FDA says that Abbott tests may be incorrectly telling users that they do not have the coronavirus.

What's next: The FDA says it is working with Abbott to review reports of inaccurate test results. Abbott has agreed to conduct further clinical studies on how the tests interact with COVID-19 positive patients, the agency said.

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