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Abbott's Rapid Covid-19 Test Investigated by FDA for Accuracy

The FDA is investigating preliminary data that found Abbott's rapid test could miss covid-19 cases.

Shares of Abbott Laboratories  (ABT) - Get Abbott Laboratories Report declined in premarket trading Friday after the Food and Drug Administration said it was investigating preliminary data that found the company's rapid test could miss covid-19 cases.

The stock fell 3.39% to $88.67.

The analysis found that Abbott’s ID Now missed at least a third of positive cases detected with a rival test and much as 48% when using the currently recommended dry nasal swabs.

The test is used daily at the White House to test President Trump and other members of his staff, including the coronavirus task force.

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Abbott rejected the findings, saying the researchers used the test “in ways that it was not designed to be used.”

The FDA warning late Thursday came a day after researchers at New York University reported the preliminary test results. The research hasn't been peer-reviewed or published in a medical journal and was based on about 100 patients, according to the Associated Press.

“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 Dr. Tim Stenzel, the FDA's director of In Vitro Diagnostics and Radiological Health. 

"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,” Stenzel added.

The FDA, in a statement on its website, said it was working with Abbott to analyze the data and "has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test."