SFUSD suspends testing pilot after FDA warning

San Francisco Unified School District is pausing its pilot program with testing startup Curative after federal officials warned last week that results through the company may result in false negatives, officials said Monday.

The U.S. Food and Drug Administration issued a warning last week of the potential for false negative results from Curative tests. While officials did not note the scope of the false tests, they warned it could result in a false sense of security and lack of timely treatment or monitoring.

SFUSD reached an agreement with Curative in November to test staff at no cost to the district that was a key component of reopening efforts. Pilot testing is now on hold, the Examiner has learned.

“Only a limited number of SFUSD staff have been tested to date with Curative labs through a small testing pilot that took place in December,” said SFUSD spokesperson Laura Dudnick. “Given the new information from the FDA, we have decided to pause our testing pilot with Curative and we are consulting further with the SF Department of Public Health while exploring other options and awaiting more information.”

Berkeley officials recommended residents not use free Curative tests for the time being and Los Angeles County officials on Sunday said they would stop using the test for mobile testing sites. The company partnered with San Francisco, San Mateo, Alameda, Sonoma, Marin, and Santa Clara for free tests. Alameda County also had an agreement with Curative to test school staff.

Curative defended the tests last week with a reminder that the tests have been validated and have specific labels. The FDA warned that the test risked false results when not administered according to authorized labeling, like being directly observed by a trained health care worker. Instructions limit use to symptomatic individuals within 14 days of coronavirus onset.

“The Department of Public Health is aware of the FDA statement about Curative self-administered tests,” said city officials in a statement. “DPH does not currently use these tests at any of its testing sites. We are interested in understanding the issue more to help guide current as well as potential future uses of this test and will be reviewing these findings and the data that support it.”

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