At-Home COVID-19 Test Gets FDA Warning: What to Know

• The FDA has announced that people should avoid using a rapid COVID-19 test made by E25Bio.
• The 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.
• People who believe there’s a problem with the COVID-19 test they’ve used are encouraged to report it using the Medwatch Voluntary Reporting Form.

The Food and Drug Administration (FDA) announced this month that people should stop using the E25Bio rapid COVID-19 test.

The agency warned that the test contains false labeling and instructions.

According to the manufacturer, 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.

“The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate,” the FDA said in a safety communication.

dr Carl Fichtenbaum, a professor of infectious diseases at the University of Cincinnati College of Medicine in Ohio, told Healthline that in an emergency, people might rush a product to market and don’t have to deal with full FDA approval.

“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 sick 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.

E25Bio has not immediately responded to Healthline’s request for comment.

The FDA warned that this test could come with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal), or from the middle part of the throat just beyond the mouth (oropharyngeal).

According to the FDA, self-collecting nasopharyngeal or oropharyngeal samples for SARS-CoV-2 testing “could result in serious injury” if not performed by a trained professional.

The agency cautioned that people attempting to collect their own nasopharyngeal or oropharyngeal swab samples risk serious injuries that include:

• injury to the tonsils/throat from use of the swab
• potentially inducing vomiting
• pieces of the swab breaking off, as they may be fragile and not designed for throat swabbing, nasopharyngeal swabbing, or self-collection

Caregivers or people who have used the test should talk with a healthcare professional if they have concerns about the test results or if they believe they were harmed while collecting a nose or throat swab sample, the agency said.

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.”

The FDA confirmed that it hasn’t received any reports of injury, adverse health consequences, or deaths associated with the E25Bio COVID-19 test.

Healthcare professionals whose patients used the E25Bio test in the past 2 weeks and suspect they received an inaccurate result should consider retesting with an FDA-authorized COVID-19 test, the FDA said.

However, people who tested more than 2 weeks ago and show no evidence of infection do not need to be retested.

“If people are concerned that their test is wrong,” agreed Fichtenbaum. “[They] should contact their doctor and get tested again to confirm results.”

According to the FDA, people who believe there’s a problem with their COVID-19 test can report it using the Medwatch Voluntary Reporting Form.

Healthcare personnel working at facilities subject to the FDA’s user facility reporting requirements can follow the reporting procedures established by those facilities.

Healthcare professionals are advised to report any problems they’ve had with E25Bio’s test to the FDA, including suspected false results or injuries from self-swabbed samples.

“Tests can be purchased at local pharmacies and online through various retailers,” said Fichtenbaum.

He added that the main issue is low supply due to the low numbers of tests available. “[Tests are] just not being manufactured almost enough for the public,” said Fichtenbaum.

He recommended that people go to https://www.cms.gov/how-to-get-your-at-home-OTC-COVID-19-test-for-free to find more information about accurate COVID-19 tests.

To find listings of FDA-authorized tests, you can also visit these links:

The Food and Drug Administration has warned against using a COVID-19 rapid test from E25Bio.

This test has not been FDA approved or authorized for sale in the United States. The recommended method to take samples is potentially dangerous.

Anyone concerned about their test results should contact their healthcare professional to be retested.

source https://www.bisayanews.com/2022/02/09/at-home-covid-19-test-gets-fda-warning-what-to-know/