As the coronavirus omicron wave spreads across the country, testing sites may become overcrowded, so you may prefer an at-home test.
However, with so many testing kits on the market, the FDA has issued a warning about one brand that may produce false findings.
“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.
According to the FDA, both versions had a “high risk of false results” and were supplied as at-home testing kits and for lab use. However, they were never “authorized, vetted, or approved” by the government for distribution in the United States.
Luscient Diagnostics, Vivera Pharmaceuticals, and EagleDx are all possible names for these tests.
Getting inaccurate results from the company’s antigen test (the nasal and saliva version) when you don’t have Coronavirus but are still not feeling well 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, receiving a negative result despite being positive for COVID-19 “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 has used LuSys Laboratories antigen and antibody tests, the FDA recommends discussing your concerns with a health care practitioner.
The FDA recommends health professionals who have tested patients with the brand’s antigen test within the last two weeks “consider retesting your patients.”
The FDA recommends issuing a report if you’ve experienced any problems with a LuSys COVID-19 test.
Several BinaxNow choices, CareStart, and BD Veritor tests are among the at-home COVID-19 antigen tests approved for emergency use, according to the government. The complete list may be seen here.
The warning comes as the United States has reported more than 61.8 million positive COVID-19 cases since the pandemic began, with the highly contagious omicron variant accounting for the majority of new cases, according to the Centers for Disease Control and Prevention.
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