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Colorado stops using Curative COVID testing due to accuracy concerns

The state's health department said it will stop using the tests in residential care facilities, prisons and other congregation locations due to FDA concerns.

COLORADO, USA — The Colorado Department of Public Health and Environment (CDPHE) announced on Thursday it will no longer use Curative COVID testing in residential care facilities, correctional facilities, homeless shelters and other congregation settings.

CDPHE said the decision was made after the Food and Drug Administration (FDA) cited additional concerns about the accuracy of the Curative assay and collection method.

The FDA issued a safety alert for the first time on Jan. 12 about the potential risk of false-negative results. CDPHE said it closely monitored Curative testing administration in the state after the alert.

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After monitoring the testing administration and receiving additional guidance from the FDA earlier this week, CDPHE said the state decided to stop using the tests in congregation settings immediately.

The decision impacts nearly 1,000 congregate facilities, according to CDPHE. Curative was averaging about 70,000 tests a week during it's contract with the state, which began in November.

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"Curative testing may still be used at some community testing sites, but should only be used on symptomatic persons with anterior nares or nasopharyngeal swabs, not oral," CDPHE said in a statement. "If an individual is asymptomatic, we advise that they seek testing at a non-Curative site."

CDPHE said that the state also expects to move away from Curative community testing sites in the coming weeks. Anyone who was tested with an oral swab at a Curative site on or after Jan. 13 is advised to get retested with an anterior nares swab.

“It’s clear that with the FDA’s most recent guidance, we need to move away from using Curative testing at congregate facilities," said Sarah Tuneberg, testing and containment manager for the COVID-19 response.  "We have a transition plan that will allow us to move quickly with minimal disruption to testing, which is a critical tool in slowing the spread of COVID-19."

>More information on the shift away from Curative testing can be found in a FAQ created by the state.

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