The FDA has issued a warning about the risk of false negatives with Curative's COVID-19 test, which is widely used in LA County.
The alert suggests health care providers who think patients may have gotten inaccurate results retest them using a different test.
Read the FDA warning here.
It notes the test should be used for people with symptoms and the specimen collection "must be directly observed and directed...by a trained healthcare worker."
"It's serious that the FDA issues this," said Dr. Peter Katona, who chairs UCLA's Infection Control Working Group and is a former epidemic investigator at the CDC. "The problem is they didn't give any data."
The alert notes the test should be used for people with symptoms.
"LA testing sites treat all comers whether they are symptomatic or not. This test is specifically for symptomatic people and not for asymptomatic people. A lot of tests are much less sensitive in asymptomatic people," he added.
At the Los Angeles testing sites, people get to watch a video with directions on how to swab themselves and do it in their vehicle.
The mayor is defending the city's use of the test.
Eric Garcetti said there aren't any tests specifically for people without symptoms and, used correctly, the Curative test has been tremendously helpful. The Curative test uses an oral swab, not a nasal swab.
But Garcetti said studies find both style of testing are equally accurate.
Curative explained in a statement that it's working with the FDA "to address their concerns" and is committed to following the agency's rules "in the development, testing and use of [its] Emergency Use Authorized test."
Curative's statement on the FDA Safety Communication- emailed to reporter Claudia Peschiutta:
Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.
We've reached out to LA City and County officials for comment.
LA County Department of Health Services had this statement Thursday afternoon: