FDA warns Curative COVID-19 test may produce false-negative results

San Antonio officials say Curative test only used for symptomatic individuals, as authorized by the FDA

FDA warning over false-negative results with Curative’s COVID-19 test
FDA warning over false-negative results with Curative’s COVID-19 test

SAN ANTONIO – The U.S. Food and Drug Administration is alerting people and test providers of the risk of false-negative results if the Curative COVID-19 test is not performed “in accordance with its authorization or as described in the authorized labeling.”

Currently, the FDA says the Curative test is authorized for use on “respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider,” the agency said.

According to Curative’s website, the tests are administered by mouth swab after a person has coughed deeply into their elbow.

The FDA states the risks of getting a false-negative result include delayed or overall lack of treatment and lack of monitoring of infected individuals and their close contacts for symptoms, resulting in an increased risk of spreading the coronavirus.

To reduce the risk of false-negative results, the FDA says COVID-19 test administrators must perform the test in accordance with its authorization and as described in the FDA’s Fact Sheet for Healthcare Providers, which can be accessed by clicking here.

Providers and patients who suspect an inaccurate result are instructed by the FDA to consider retesting using a different method.

“A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19,” the FDA says on its website.

Curative tests are used at a number of the city’s testing sites. San Antonio Assistant City Manager and interim Metro Health Director Dr. Colleen Bridger said the city testing sites use Curative tests only for symptomatic people.

“Per the FDA’s emergency use authorization of these tests, the City has been using Curative tests for symptomatic individuals. We intentionally partnered with Community Labs to provide testing for asymptomatic individuals at our no-cost test sites.”

Click here to learn more about the FDA’s recent safety communication.

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