Healthline: At-Home COVID-19 test gets FDA warning: What to know
UC infectious disease expert says the biggest risk is a false negative test
The Food and Drug Administration (FDA) announced recently that people should stop using the E25Bio rapid COVID-19 test. The agency warned that the test contains false labeling and instructions. The manufacturer says the E25Bio test uses a “novel technology” that is more accurate than a PCR test “without the need for equipment and at a fraction of the cost and time.”
However, according to the FDA, this test hasn’t been “authorized, cleared, or approved” by the FDA for distribution or use in the United States and may include false labeling claiming that the test is authorized by the FDA.
In a story published by Healthline, Carl Fichtenbaum, MD, of the Division of Infectious Diseases at the UC College of Medicine was the only expert source cited, saying that in an emergency, manufacturers might rush a product to market and don’t have to deal with full FDA approval.
Carl Fichtenbaum, MD, of the Division of Infectious Diseases at the UC College of Medicine/Photo/Colleen Kelley/UC Creative + Brand
“Usually, this is uncommon as most retailers typically sell products that are FDA approved,” he added.
Fichtenbaum explained that the main danger is a false negative test.
“If someone really has COVID, and then assumes they don’t based upon a faulty or inaccurate test, they could infect others and become sicker themselves and not seek medical attention as quickly as they should,” he said.
According to Fichtenbaum, false positives can occur, and this could cause unnecessary concern and worry.
“Also, if people isolate, they might lose income or their job,” he continued.
The dangers associated with taking your own samples aren’t the biggest issue, Fichtenbaum said. The main concern is “inadequate” sample collection.
“People may not swab correctly or collect the right amount of saliva,” he said. “This can lower the effectiveness of the test and provide mostly false-negative results.”
Lead image/Boston 25 News
Next Lives Here
The University of Cincinnati is classified as a Research 1 institution by the Carnegie Commission and is ranked in the National Science Foundation's Top-35 public research universities. UC's medical, graduate and undergraduate students and faculty investigate problems and innovate solutions with real-world impact. Next Lives Here.
Related Stories
These teeny spiders are social media stars
August 28, 2026
The New York Times turned to a University of Cincinnati professor to explain the appeal of jumping spiders on social media.
An internal divide among unions on AI impacts the Wisconsin gubernatorial race
August 28, 2026
Anne Lofaso, a professor in the Donald P. Klekamp College of Law at UC, spoke with Wisconsin Public Radio, about the schism among unions over AI and whether it is a plus, a negative, or somewhere in between when looking at job creation.
On-site training in Speech & Hearing Clinic sets UC’s programs apart
August 27, 2026
At the University of Cincinnati’s Speech & Hearing Clinic, Doctor of Audiology and Speech-Language Pathology graduate students gain real-world experience while providing free speech and hearing services to the community.