FDA cracks down on use of LuSys Labs' unauthorized COVID tests

The FDA is once again asking consumers and healthcare providers not to use COVID-19 tests that have found their way into regular distribution despite not having been cleared by the agency.

Latest on the chopping block are antigen and antibody diagnostics from LuSys Laboratories. The tests haven’t received any marketing clearance or emergency authorization and likely carry a “high risk” of returning incorrect results, the FDA said in a Jan. 11 warning letter.

LuSys’ tests can be found under a handful of company and product names, including Luscient Diagnostics, Vivera Pharmaceuticals and EagleDx. The agency said it believes the tests have been distributed under these names for both laboratory and at-home use.

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Patients and providers who have purchased or used the tests and suspect that they received inaccurate results are advised to retest—if the questionable result arrived within the previous two weeks—and notify the FDA of any issues with the diagnostics, including suspected false results.

Both the antigen and antibody tests are at risk of producing either false-positive or false-negative results.

In the case of the former kits, which analyze a nasal or saliva swab to detect active COVID-19 proteins, false positives could delay the correct diagnosis and treatment of the underlying issue causing COVID-like symptoms, “which could be another life-threatening disease,” per the FDA. False-negative antigen results, meanwhile, could not only keep someone who is actually infected with the virus from being properly treated but could also lead to its rapid spread—both instances that could lead to severe illness or death.

The antibody tests rely on a serum, plasma or blood sample to find antibodies produced in response to a previous coronavirus infection, rather than detecting an active case. Both false-negative and false-positive results from these tests “could lead test users to take fewer precautions” to protect themselves and others from future infections, the FDA said, if users falsely believe that they either already had COVID, are incorrectly using the test as a real-time indicator of if they’re currently contagious.

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Since the start of the coronavirus pandemic, the FDA has made a mission of cracking down on unauthorized sales of tests and treatments for the virus. Last year, it issued warning letters about tests from Innova Medical Group and Lepu Medical Technology that were being distributed to pharmacies, healthcare providers and directly to consumers, even though neither company's diagnostics had been cleared by the FDA.

This also isn’t the first time the agency has issued a warning regarding tests from LuSys. Back in 2015, the San Diego-based company was forced to recall more than 2,000 of its unapproved Ebola Virus One-Step Test Kits. The recall was given the FDA’s most severe Class I rating and resulted in all unused test kits being destroyed.