FDA says stop using Empowered Diagnostics at-home COVID tests after concerns of false negative, positive resu – MassLive.com

The U.S. Food and Drug Administration is advising individuals to stop using COVID-19 tests produced by Empowered Diagnostics due to the possibility of each producing a false result.

The FDA said on Friday that Empowered Diagnostics’ CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test were each distributed with labeling indicating they are authorized by the agency, however neither test had met any kind of approval.

Empowered Diagnostics is recalling both tests.

Anyone who used the test within the last two weeks should consider getting retested, the FDA said.

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect the virus. The FDA is concerned the rapid test could give incorrect results including both false negative and false positives.

A false-negative test result means that the test says the person doesn’t have COVID but the person is actually infected.

The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by a person’s immune system in response to the coronavirus.

Antibody tests detect if a person may previously have been infected with COVID. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection, the FDA says.

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