COVID-19 test that may have inaccurate results used across Bay Area, FDA warns



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The COVID-19 test used at dozens of sites across the Bay Area can lead to false negative results.

The United States Food and Drug Administration issued a warning on Monday that the COVID-19 test developed by Curative, the Bay Area start-up that calls its tests “easy to use and painless,” runs the “risk of false results, in particular 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 onset of symptoms of COVID-19.”

“A negative result does not exclude the possibility of COVID-19” if used on individuals without any symptoms, he warned.


The FDA explained that the risks of false negatives include “the delay or absence of supportive treatment” and “the lack of monitoring of those infected … leading to an increased risk of the spread of COVID-19 within the community. community”.

Curative has partnered with six Bay Area counties – San Francisco, San Mateo, Alameda, Sonoma, Santa Clara and Marin – for their free testing.

Marin County is the latest county to work with the startup, announcing a large rollout of contextual 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 “was aware” of the FDA’s statement on curative testing.

“DPH does not currently use these tests at any of its test sites,” the statement said. “We want to better understand the problem to help guide current and potential future uses for this test, and we will be looking at these results and the data that supports it.”

Schools in San Francisco also offered to use Curative to test teachers and school staff when they reopened, a partnership that was established in November of last year.

A statement from the San Francisco Unified School District to SFGATE states, “Only a limited number of SFUSD staff have been tested to date with curative laboratories through a small pilot project that took place in December. new information from the FDA, we have decided to suspend our pilot test with Curative and are further consulting with the SF Department of Public Health while exploring other options and awaiting more information. “

Curative was founded by Fred Turner, a 25-year-old British businessman. The company was founded in early 2020 to focus on sepsis and pivoted at the start of the pandemic to focus on the coronavirus.

In a statement to SFGATE, Turner said the company will work with the FDA on the issue.

“We are confident in our data and are working closely with the FDA on this issue,” he said in a statement. “Testing sensitivity and accuracy on behalf of our patients is at the heart of our work.”

NBC News reports the company has been awarded a federal contract to perform tests on U.S. government officials. He also obtained contracts with the Department of Defense and the US Air Force.

Bay City News Service contributed to this report.

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