Tuesday, July 5, 2022

U.S. FDA alerts on false positive result from Becton Dickinson COVID-19 test

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The U.S. Food and Drug Administration alerted clinical laboratories and healthcare providers on Monday about false positive results from one of Becton Dickinson and Co’s COVID-19 molecular diagnostic tests.

The test, designed to detect viral nucleic acid from the virus that causes COVID-19, is in use in nearly every state across the U.S. at hundreds of laboratories.

In one study, the manufacturer found about 3% of the results were false positives, according to the FDA.

The health regulator said it was working with Becton Dickinson to resolve the issue.

Becton Dickinson is selling a variety of other types of tests for the coronavirus. The FDA on Monday granted emergency use authorization to the company’s COVID-19 antigen test that can be administered at the point of care, with results within 15 minutes.

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