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First OTC COVID Test Recalled

— Certain lots of Ellume's at-home test have higher rate of false positives, FDA says

by Molly Walker, Deputy Managing Editor, 番茄社区

番茄社区 MedicalToday
A photo of the Ellume COVID-19 home test kit

Ellume is recalling certain lots of its at-home COVID-19 antigen test due to a higher than acceptable false-positive rate, the .

If a patient received a positive result from one of the affected lots in the past 2 weeks, they should follow up with a healthcare provider for a molecular diagnostic test to confirm the result, the agency added.

FDA initially granted emergency use authorization (EUA) to the Ellume test in December 2020, for which a patient performs their own nasal swab and a smartphone app interprets the results of their test. It was the first over-the-counter COVID-19 test authorized by the agency.

The recall affects more than 2 million testing devices, and has been designated as class I by the FDA -- the most serious type of recall. In explaining this, the agency enumerated several reasons why a false-positive test result might "cause serious adverse health consequences or death." The agency noted that there have been 35 reports of false-positive tests sent to FDA, but no associated deaths.

A false positive could lead to serious COVID-related and non-COVID-related consequences, such as delaying diagnosis of a non-COVID illness and side effects from unnecessary COVID treatment, including antivirals and monoclonal antibodies. They also warned of further spread of the virus due to misclassification of status (i.e., putting someone into a group with people who actually tested positive for COVID could lead to that person contracting the virus for real).

Interestingly, the agency seemed to take a swipe at the natural immunity argument, stating that a false-positive test could cause someone to "disregard ... the recommended precautions against COVID-19, including vaccination," implying that someone who falsely believes they have immunity might not get vaccinated.

The FDA also warned of "isolation" due to limited contact with family or friends and missing school or work because of a false-positive test.

The agency noted that these tests were distributed from April 13 to August 26 of this year.

Negative results with this test are still reliable, they added.

  • author['full_name']

    Molly Walker is deputy managing editor and covers infectious diseases for 番茄社区. She is a 2020 J2 Achievement Award winner for her COVID-19 coverage.