Stop using these COVID tests, FDA warns. There’s a ‘higher risk’ of false positives
There’s a “serious” recall for some COVID-19 tests distributed with misleading labeling saying they’re authorized by the Food and Drug Administration when they’re not, the agency is warning.
The FDA is urging everyone to stop using two tests made by U.S. company Empowered Diagnostics – the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
“Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States,” the agency said in a Jan. 28 news release, adding it’s “concerned about the potentially higher risk of false results when using unauthorized tests.”
The warning comes as the coronavirus omicron variant continues to spread and dominate positive virus cases in America for the past six weeks as of Feb. 1, according to Centers for Disease Control and Prevention data.
Empowered Diagnostics initiated the recall of their two tests on Dec. 22 and the FDA “has identified this issue as a Class I recall, the most serious type of recall.”
Getting a false positive result from the CovClear COVID-19 Rapid Antigen Test — a nasal swab sample test — when you’re feeling sick but don’t have COVID-19 “may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease,” the FDA warns.
Additionally, getting a negative result when you’re actually COVID-19 positive “may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death,” the agency said.
Seeing a false positive from the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test — a fingerstick blood sample test — can mislead a person into thinking they have antibodies against the virus when they don’t, according to the FDA.
This “could lead test users to take fewer precautions to protect themselves from” infections in the future.
A false negative result signals that a person doesn’t have antibodies to COVID-19 when they do, the agency said.
If you or someone you know have used either recalled test by Empowered Diagnostics, the agency suggests raising concerns with a health care provider.
Health workers who’ve tested patients using the rapid antigen test “less than two weeks ago (should) consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test,” the FDA advises. Those who’ve tested patients with the antibody rapid test are advised to “consider retesting” patients with an FDA authorized antibody test.
If you’ve had issues using any COVID-19 test, the agency encourages you to report it.
The FDA lists a number of antigen diagnostic tests authorized for emergency use and the full list can be viewed here.
This story was originally published February 1, 2022 at 1:04 PM with the headline "Stop using these COVID tests, FDA warns. There’s a ‘higher risk’ of false positives."
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