FDA Warns Abbott Coronavirus Tests Could Be Inaccurate

TOPLINE

The Food and Drug Administration issued an alert Thursday warning that Abbott Laboratories’ rapid COVID-19 tests may deliver inaccurate results, a major setback for the testing system commonly used around the U.S. as the country looks to ramp up its testing capacity.

KEY FACTS

Crucial quote

“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,” said Tim Stenzel, , director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.

Key background

Abbot has previously said that false negatives could arise because samples were being stored in a solution instead of being put directly into the company’s testing machine, according to NPR, causing the company change its instructions in April by telling users to not use the solution. Abbott’s tests are used by the White House to test members of the administration, including President Donald Trump himself.

News peg

U.S. testing capacity has ramped up significantly since the early days of the outbreak. According to the COVID Tracking Project, the U.S. has averaged 345,000 tests per day since Monday, far more than this time last month. But public health experts say the U.S. needs to increase testing even more before reopening. 

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