FDA warns LuSys COVID-19 test kits inaccurate

False COVID-19 test results can harm individuals and members of the public, says FDA

The Food and Drug Administration is warning individuals against using COVID-19 tests manufactured by LuSys Laboratories, saying the test kits are not “adequately established” and are prone to giving false results.  

“A false negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death,” the FDA says.  

LuSys offers both antigen and antibody tests, however, the FDA claims neither has been authorized, cleared, or approved by the governing body.  

The tests are either sold under the company names Luscient Diagnostics and Vivera Pharmaceuticals, or using the trade name EagleDx, the FDA says.  

A COVID-19 antigen tests involves using saliva or a nasal swab, while an antibody test requires a blood sample, serum, or plasma.  

The tests can possibly give both false positive and false negative results, according to the FDA, which didn’t specify on which was more likely to occur.  

“A false positive result may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19,” said the FDA.  

The FDA recommends anyone who has used a test from LuSys Laboratories and is concerned about their results to speak with their healthcare provider. 

The agency is also recommending health care professionals to consider retesting any patients who have they have used an affected test kit on in the past two weeks.