The COVID-19 Test The FDA Now Says You Can't Trust

San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo authorization from the U.S. Food and Drug Administration (FDA) for its at-home COVID-19 test kit. Less than a year later, the FDA has now asked medical professionals as well as regular users to stay away from it due to the risks of false test results. "Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have," says the agency in a press release.

Earlier this month, the US FDA issued a warning to Cue Health for not notifying it about some key changes made to the tests. But it was not the unnotified changes that raised alarms, but the fact that these tweaks reduced the accuracy of detecting the SARS-CoV-2 virus' presence in the bio-samples.

"The release of products that fail to meet their claimed performance could lead to an increase in false positive results," the agency said in its warning issued to the company. Cue Health is said to have made substrate changes that modify the electrochemical signals that affect the stability of the whole kit and performance. Interestingly, in October last year, a peer-reviewed study that was published in the Microbiology Spectrum journal claimed that Cue Health's Molecular COVID-19 test was as accurate as PCR tests done in clinical settings. However, it is unclear if Cue Health made the changes to its test kits before or after the research was published.

The FDA has issued separate guidelines for regular users, caregivers and healthcare professionals in possession of the testing kits. If you have Cue Health's COVID-19 Tests for Home and Over the Counter (OTC) Use and its COVID-19 Test kits, the agency says you should dump the entire test cartridge safely in the trash. If you were tested previously using Cue Health's offering and are now having second thoughts about the test accuracy, you should consult a certified healthcare professional and get a fresh test done using a different FDA-cleared COVID testing kit.

A fresh test is recommended, especially if you got a negative result but are still exhibiting symptoms. The FDA's warning letter to Cue Health mentioned issues with stability and performance. So, if you're having any technical issues with a test kit at home, the FDA suggests you should report the same via the MedWatch Voluntary Reporting Form.

For healthcare professionals and certified caregivers who are still in possession of the aforementioned test kits, the FDA advises against using them and has urged that the hardware be disposed of responsibly. If possible, they should also test their patients again, especially if testing was done using one of Cue Health's kits less than two weeks ago.