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Abbott test praised by Trump, used at White House may give false negatives, FDA says

Companies racing to get approval for new coronavirus tests
Posted at 9:41 PM, May 14, 2020
and last updated 2020-05-14 21:41:23-04

WASHINGTON — The FDA issued an alert Thursday, questioning the accuracy of a COVID-19 point-of-are test from Abbott — a test that President Donald Trump touted publicly as being "highly accurate," and is used to test his staff.

The noticed from the FDA said early data suggests potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

"We will continue to study the data available and are working with the company to create additional mechanisms for studying the test," he said.

Stenzel said the test can still be used if multiple positives are determined, but negative tests need to be confirmed with a different type of test.

The Abbott point-of-care test is used at the White House.

The FDA said it has been working with Abbott to analyze the information and to alert users.

They said anyone that tests negative but has symptoms of COVID-19 should get another test.