Don’t use this at-home COVID test, FDA warns. It could give you a false positive
As the coronavirus omicron wave sweeps across the country, testing centers can become busy and you might be looking for an at-home test as an alternative.
But with variety of testing kits on the market, the Food and Drug Administration is now warning of a brand that could give inaccurate results.
“Stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test,” the agency urged on Jan. 11 in a news release.
Both versions have a “high risk of false results” and are believed to have been distributed as at-home testing kits and for lab use, according to the FDA. However, they were never “authorized, cleared, or approved” by the agency for U.S. distribution.
These tests might also be sold under names including Luscient Diagnostics, Vivera Pharmaceuticals and EagleDx.
Getting a false positive from the company’s antigen test (the nasal and saliva version) when you don’t have COVID-19 but are still feeling sick might delay “both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness,” the FDA warns.
Additionally, getting a negative result when you’re actually COVID-19 positive “may lead to delayed diagnosis or inappropriate treatment of (COVID-19), which may cause people harm including serious illness and death,” the agency said.
If you or someone you know have used LuSys Laboratories antigen and antibody tests, the agency suggests raising concerns about the results with a health care provider.
Health workers who’ve tested patients using the brand’s the antigen test within the past two weeks should “consider retesting your patients” the FDA advises.
If you’ve had any issues using a LuSys COVID-19 test, the FDA advises issuing a report.
The agency lists a number of at-home COVID-19 antigen tests authorized for emergency use such as a few different BinaxNow options, CareStart and BD Veritor tests. The full list can be viewed here.
The agency’s warning comes as the U.S. has had more than 61.8 million positive COVID-19 cases since the start of the pandemic and as the highly contagious omicron variant makes up a majority of new cases, according to the Centers for Disease Control and Prevention.
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