FDA Warns of Possible False Results From Some COVID-19 Tests

Doctor or medtech shows rapid laboratory COVID-19 test to detect IgM and IgG antibodies to Novel Coronavirus, SARS-CoV-2 with positive result. Immunity against Covid-19, respiratory viral pneumonia. anyaivanova/Shutterstock

The U.S. Food and Drug Administration (FDA) on March 1 said that three rapid COVID-19 tests shouldn’t be used because of the potential for producing false results.

The FDA told people to avoid using the Celltrion DiaTrust COVID-19 Ag Rapid Test, the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test, and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

“The FDA is concerned about the risk of false results when using” those tests, according to the agency. These tests have “not been authorized, cleared or approved by the FDA for distribution or use in the United States,” the agency said.

All three tests work via nasal swab, the agency added. It recommended that health care providers have patients submit to new testing if they’ve used any of the three tests in the past two weeks.

FDA

The FDA said ACON Laboratories has recalled all of its Flowflex tests, SD Biosensor has recalled its tests, and Celltrion USA has recalled all of its DiaTrust tests.

“People should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging,” the FDA said, including a photo of the test.

FDA

SD Biosensor’s “unauthorized test may be packaged in a white and magenta box,” the FDA said.

ACON Laboratories’ tests are packaged in a dark blue box, according to the agency.

FDA

The FDA said it has “not received reports of injuries, adverse health consequences, or death associated with use of” any of the three tests.

In a statement, ACON Laboratories stated that the unauthorized tests are an “adulterated and misbranded counterfeit product.”

In February, the FDA issued warnings about the E25Bio COVID-19 Direct Antigen Rapid Test, the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test, and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test for similar reasons. Recalls were also initiated for the tests.

“The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test,” the health agency said in a statement at the time. “These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.”

The warning comes as some poison control centers warned people not to improperly use at-home COVID-19 tests because they contain sodium azide, a potentially toxic substance. Some local poison control centers and hospitals have warned about an uptick in phone calls about exposures to the chemical.

Tests made by Flowflex and Celltrion contain the substance.

COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.