The FDA issued a warning Jan. 4 about the risk of false results, particularly false negative results, with Curative's COVID-19 test.
The agency didn't specify any issues with the test, but said it's important to perform the test according to its emergency use authorization, which states that it should only be used in symptomatic people within 14 days of their symptoms developing. It also specifies that people taking the test, which is self-administered, must be directly observed by a trained healthcare worker during sample collection.
The FDA is recommending that providers use a different test if they suspect a patient's recent results from the Curative test may not be correct, but those tested more than two weeks ago don't need to be retested unless they suspect they have the virus.
Curative said it's working with the FDA but is confident in its data for the test, KXAN, a local NBC affiliate in Austin, Texas, reported.
"Testing sensitivity and accuracy on behalf of our patients is at the heart of our work. Curative will be providing additional updates and information soon," Curative CEO Fred Turner said in a news release.