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FDA warns of COVID-19 test that may give false positive

A study by the manufacturer found approximately 3% of this particular test system resulted in false positives.

The Food And Drug Administration is alerting clinical laboratories and health care providers that one particular test for COVID-19 has an increased risk of false positive results. 

A study by the manufacturer found that approximately 3% of the Becton, Dickinson and Company (BD) SARS-CoV-2 Reagents for the BD Max System tests resulted in false positives.

The test was granted an Emergency Use Authorization on April 8. 

"The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs," the FDA said in a statement.

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The FDA is urging health and lab professionals to consider positive results from the test presumptive and to confirm with anotherauthorized test. The agency said it is working with BD to resolve the issue with the false positives.

There have been more than 3 million confirmed cases of COVID-19 in the U.S., according to Johns Hopkins University. It is unknown how many of those results came from the BD SARS-CoV-2 Reagents for the BD Max System, or if any of those results were re-verified using an alternate test.

For most people, the virus causes mild or moderate symptoms. But it can cause severe symptoms in and be fatal for others, especially older adults and people with existing health problems.

The Associated Press contributed to this report.

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Credit: AP
Eric Antosh has a nasal swab taken by a nurse at a COVID-19 testing site in Brooklyn run by NYC Health + Hospitals as part of the "Get Tested Day of Action," Wednesday, July 8, 2020, in New York. (AP Photo/Mark Lennihan)