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City Has ‘Confidence’ In Curative’s Coronavirus Tests Despite Warning Of False Negatives From FDA

The FDA's alert highlights that the tests can be safely used how they're being used in Chicago, said Dr. Allison Arwady.

A technician gives instruction as folks line up for free COVID-19 tests at Pritzker College Prep in Chicago's Hermosa neighborhood on Monday, November 30, 2020.
Colin Boyle/Block Club Chicago
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CHICAGO — The city’s health department will continue to use Curative’s coronavirus tests at its community test sites despite a warning of the potential for false negative results.

The FDA issued an alert Jan. 4, warning the tests could provide false results, particularly false negatives. False negatives could delay someone getting treated or could result in a person not quarantining appropriately, according to the federal agency.

Dr. Allison Arwady, head of the Chicago Department of Public Health, said Chicago will continue using the Curative tests for now. The city has four static testing sites open weekdays and hosts mobile testing drives where people can get a COVID-19 test for free. Chicagoans have been tested more than 2.5 million times.

The FDA’s alert highlights that the tests can be safely used how they’re being used in Chicago, Arwady said.

“Obviously, we follow very closely everything related to any of our testing and anything that comes out from the FDA,” Arwady said at a Thursday morning vaccination update. “We feel very confident, based on what we’ve seen at this point, related to this test. We do not have plans to move away from it … .”

In response to the FDA alert, some testing sites in Los Angeles County have opted to stop using the tests.

But Arwady said the city of Los Angeles, which makes up the “great majority” of tests being done in the area, is also continuing to use the Curative tests, and they’re being used in other places around the United States.

The FDA issued the alert because Curative asked for permission to expand so people could use the tests in unmonitored settings, like at home, Arwady said. The FDA denied that request and put out the alert to emphasize the tests are best used under supervision and on people who have symptoms of COVID-19.

“To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers,” according to the FDA alert. “When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate.”

The alert also provides recommendations for how health care providers, patients and caregivers can use and understand the Curative tests.

At Chicago’s testing sites, samples for the tests are collected by health care providers.

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