The U.S. Food and Drug Administration is warning individuals not to use a specific brand of rapid COVID-19 testing because they may produce erroneous findings.
The tests - Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test - are labeled as FDA-authorized, but they have not been authorized, cleared, or approved by the agency, according to the FDA.
The FDA advises anyone who utilized the tests within the last week to retest with an FDA-approved fast kit. A full list of approved quick kits can be found here.
If you took the test more than two weeks ago and have no symptoms, the agency says you don't need to retest.
"The FDA is concerned about the potentially higher risk of false results when using unauthorized tests," the agency said, adding it has issued the most serious type of recall for items - a Class I recall.
The CovClear tests collect samples for COVID-19 testing via a nasal swab, whereas the ImmunoPass test finds COVID-19 antibodies acquired from a previous infection using a fingerstick blood sample. Both tests may produce misleading negative results, resulting in a lack of treatment or unintended infection propagation.
If you took the test within the last two weeks, the FDA suggests retaking it with an FDA-approved fast kit. It is not essential to retest if the test was performed more than two weeks ago and there is no indication to assume a current COVID-19 infection.
The FDA also advised against using self-collected throat swabs for COVID-19 tests in January, stating that people should only use the tests as directed.
Following anecdotal reports of sore throats associated with coronavirus infection and preliminary research suggesting that saliva may be a better way to identify the Omicron variety, some people began swabbing their throats using antigen test swabs designed for nose samples. People began posting their results on social media with the hashtag #SwabYourThroat, and the home test was born.
In some places, throat swabs are common. Some rapid tests for patients without COVID-19 symptoms may require both a nose swab and a throat swab, according to the National Health Service in the U.K. However, most self-tests in the United States require nasal specimens, with a few requiring saliva collected by spitting into a tube.
People who used the recalled test and believe they had an issue with it can use the MedWatch Online Voluntary Reporting Form to report it.
