There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests.
The agency “is concerned about the risk of false results when using” all three, it said on Tuesday, March 1, about certain COVID-19 antigen tests by companies Celltrion, ACON Laboratories and SD Biosensor. Each company has issued their own recalls for their particular kits.
Avoid the Celltrion DiaTrust COVID-19 Ag Rapid Test found in bright green and white packaging and the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) found in a dark blue box, the FDA says. Additionally, don’t use SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test found in a white and magenta box.
If you have a test by any of these three companies, compare the packaging with the photos shared by the FDA of the unauthorized tests. Other COVID-19 tests by each company are authorized.
At least 162,000 unauthorized Celltrion COVID-19 tests that were distributed involve using a nasal swab to detect virus antigens, according to the FDA. They have “the same name as an FDA authorized version of the test for point of care settings but is not the same test,” the agency warns.
You can continue to use Celltrion’s DiaTrust COVID-19 Ag Home Test and the safe DiaTrust COVID-19 Ag Rapid Test that are both FDA-authorized and “not affected” by the agency’s warning.
The unauthorized tests by ACON Laboratories is also a nasal swab test to detect antigens and has “lettering and symbols in the lower right corner of the box, including the letters ‘CE.’”
The ACON Laboratories Flowflex COVID-19 Antigen Home Test is different and still FDA-authorized, according to the agency.
The unauthorized SD Biosensor STANDARD Q COVID-19 AG Home Test is another nasal swab test used to detect virus antigens.
However, this SD Biosensor COVID-19 At-Home Test is FDA-authorized and is “a different test” distributed by Roche that’s safe to use, the agency says.
Antigen tests are meant to detect virus antigens to quickly notify a person if they’re COVID-19 positive or negative, according to the FDA. A false-negative result “says the person does not have COVID-19 but they actually do have COVID-19” and vice versa.
If you or someone you know has any of the three unauthorized tests, the agency suggests raising concerns with a health care provider.
Health workers who’ve tested patients using the antigen test of concern within the past two weeks should “consider retesting your patients” the FDA advises.
The FDA says to report issues with using any COVID-19 test.
The FDA’s warnings come as COVID-19 cases continue to drop in the U.S., according to the Centers for Disease Control and Prevention. Average weekly cases as of Feb. 23 dropped by 37.7% compared to the week prior.
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