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FDA : Abbott's Rapid Coronavirus Test May Deliver Inaccurate Results

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The U.S. Food and Drug Administration warned that an early data suggested that Abbott' rapid coronavirus diagnostic test for Covid-19 may deliver inaccurate results.

The Abbott ID NOW point-of-care test may return false negative results, the FDA said.

The FDA alert comes a day after New York University researchers reportedly alleged that the Abbott ID NOW test missed a third of samples collected with nasal swabs that tested positive with a test from rival Cepheid.

The FDA said that it is still evaluating the information about inaccurate results and is in direct communications with Abbott about the important issue.

Meanwhile, Abbott said the NYU study results are not consistent with other studies.

"While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method," Abbott said in a statement.

Abbott said it has been working in collaboration with FDA throughout the Emergency Use Authorization process.

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