The COVID-19 test used at dozens of locations across the bay area can lead to false negative results.
The US Food and Drug Administration issued a warning on Monday that the COVID-19 test developed by Curative, the Bay Area start-up that marks its tests as “simple to use and painless”, is at “risk of false results , particularly false negative results. “
The reason for this, the agency explained, is that the test should only be used on “symptomatic individuals within 14 days of the onset of COVID-19 symptoms.”
“A negative result does not exclude the possibility of COVID-19” if used in individuals without any symptoms, he warned.
The FDA explained that among the risks of false negatives are “delay or lack of supportive treatment” and “lack of monitoring of infected individuals … resulting in an increased risk of spreading COVID-19 in the community”.
Curative has partnered with six counties in the Bay Area – San Francisco, San Mateo, Alameda, Sonoma, Santa Clara and Marin – for free trials.
Marin County is the youngest to work with the startup, announcing a widespread deployment of pop-up test sites using the company’s technology.
A representative from the COVID Command Center in San Francisco told SFGATE in a statement that the Department of Public Health “is aware” of the FDA statement on curative testing.
“DPH does not currently use these tests at any of its test sites,” says the statement. “We are interested in understanding the problem further to help guide the current and future uses of this test and will review these findings and the data that support them.”
Schools in San Francisco have also proposed using Curative to test teachers and school staff when they reopen, a partnership that was established in November last year.
A San Francisco Unified School District statement to SFGATE says: “Only a limited number of SFUSD employees have been tested with curative labs so far through a small pilot test that took place in December. Given the new information from the FDA, we decided to pause our test pilot with Curative and we are consulting with the SF Department of Public Health further as we explore other options and await more information. “
Curative was founded by Fred Turner, a 25-year-old British businessman. The company was originally founded in early 2020 to focus on sepsis and spun at the beginning of the pandemic to focus on coronavirus.
In a statement to SFGATE, Turner said the company would be working with the FDA on the matter.
“We are confident in our data and we are working with the FDA on the matter,” he said in a statement. “Testing sensitivity and accuracy on behalf of our patients is at the heart of our work.”
NBC News reports that the company has obtained a federal contract to conduct tests on US government officials. He also won contracts with the Department of Defense and the United States Air Force.
Bay City News Service contributed to this report.