FDA warns of false results with COVID-19 test used at some Bay Area sites

BERKELEY, Calif. (KTVU) - The Federal Drug Administration issued a warning about a particular COVID test that is being used in counties all over the Bay Area.

The administration said Curative, a self-administered oral swab test, has a "risk of false results, particularly false-negative results."
 
 "The FDA doesn't do that lightly," said Dr. John Swartzberg, an infectious disease specialist at UC Berkeley.
 
He said physicians have reported complaints about their patients. It even happened on Capitol Hill, where Curative's oral self swab was used to test members of Congress.
 
"They lost their sense of smell, taste, they ached all over. They had fever and cough. I mean they had COVID and yet these tests were negative. It was these kinds of reports that led to the FDA investigating it. And they found there were just too many false negatives," said Swartzberg.
 
Curative's founder Fred Turner, who was 25 years old when he launched the startup, released a statement that read, "We are confident in our data and we are working with the FDA closely on the matter. Testing sensitivity and accuracy on behalf of our patients is at the heart of our work."
 
The company emphasizes the test is only approved for people who are symptomatic.
 
"A lot of the problem is water under the bridge unfortunately. People who have been tested and who have carried on their lives thinking they didn't have COVID when they did, well they probably spread it to a lot of other people," said Swartzberg.
 
Multiple Bay Area counties have partnerships with Curative. Santa Clara County says they're in discussions about the warning.
San Mateo County plans to add information to their website.
And Marin County says they're continuing their partnership for now.
 
They all point out that no test is 100% accurate.
 
Still, doctors say don't take this lightly.
 
"You don't see FDA warnings like this unless they have a lot of data to support their concerns. So I would take those warnings very seriously. And until there is much more clarification, I would prefer getting a test from another company," said Swartzberg.