Colorado halting use of Curative tests at congregate facilities, moving away from use at local sites

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DENVER – Effective Thursday, Colorado will no longer use Curative COVID-19 tests at residential care facilities, correctional facilities, shelters and other congregate care settings after further warnings from the U.S. Food and Drug Administration about false negatives with the tests and issues with the test’s assay.

The Colorado Department of Public Health and Environment said nearly 1,000 facilities of those types had been using the tests over the past three months and that about 70,000 Curative tests per week had been done in the state since its contract with the state came online in early November.

The state said that 715,619 Curative tests had been performed in Colorado as of Jan. 19.

Thee CDPHE said it would halt usage of the test at the congregate facilities after warning on Jan. 12 that it was “closely monitoring” the Curative test and its administration to people.

That notice came after the FDA issued a safety alert that day warning about false negatives with the test and improper administration of the test by some providers. The CDPHE said at the time that the Curative test, which did receive an Emergency Use Authorization from the FDA, that it believed the tests would still be “a reliable option in the context of FDA guidance.”

But the department said that further concerns from the FDA led them to make the decision announced Thursday.

The FDA’s latest warning about the Curative tests says it should only be used under three conditions: if a person is symptomatic and within 14 days of the onset of symptoms; if specimen collection is supervised; and when an oral test gives a negative reading, it must be confirmed with a different method.

In addition to using the tests at some congregate care facilities, the state has also been using Curative tests at several mobile and drive-through community testing sites set up across the state with local public health departments., including some larger sites at Denver International Airport, the Jefferson County Fairgrounds and the University of Northern Colorado – all of which were still operating this month.

The CDPHE said Thursday it plans to transition away from using the Curative tests at community testing sites as well in coming weeks. The department is advising people who got tested at Curative sites on Jan. 13 or after with an oral swab who received negative results to be tested again with an anterior nares swab.

The CDPHE said that sites still using Curative tests in the meantime should only use them on symptomatic people with anterior nares or nasopharyngeal swabs and not oral swabs. It is advising people who are asymptomatic to get tested at a non-Curative site.

“We are committed to providing all Coloradans with access to reliable tests,” said Sarah Tuneberg, the testing and containment manager for the state’s COVID-19 response. “It’s clear that with the FDA’s most recent guidance, we need to move away from using Curative testing at congregate facilities. 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. We remind Coloradans that testing, while critical, is just one tool in our toolbox. We all need to continue to follow public health protocols, like mask wearing, avoiding large gatherings, and physical distancing.”

The state said it had “no evidence” that Colorado saw “excess inaccurate results” because of the Curative tests and that it was not aware of any instances in which false negatives led to more outbreaks in the congregate care facilities.

Other community testing sites operating in January that have been using Curative tests include sites in Park, Clear Creek, Douglas, Jefferson, Logan, Washington, Sedgwick, Morgan, Yuma, Garfield and Montrose counties, but some are no longer operational, according to Curative’s site.

Jefferson County Public Health said Thursday afternoon it would no longer offer Curative testing and that the Jeffco Fairgrounds site and Curative Mobile Vans in Conifer and Evergreen would be temporarily closed before reopening in partnership with the CDPHE’s Rapid Response Team.

JCPH said the Jeffco Fairgrounds site would reopen on Saturday and the Conifer and Evergreen testing sites would reopen on their normal schedules of Wednesday and Sunday.

“Testing for COVID-19 remains one of the most important tools for fighting the virus, and JCPH is committed to ensuring accurate and reliable testing is widely available to our residents,” said Christine Billings, Manager, Office of Pandemic Response at JCPH. “We want to assure residents there will be very minimal testing disruption as a result of this change.”

The CDPHE said it was working with its contracts and fiscal teams, as well as the Colorado Attorney General’s Office, to “ensure changes to or termination of the contract with Curative is not a cost borne by Colorado’s taxpayers.”

Curative said in a statement it was working with the FDA to address the departments concerns and to give them more data to “address these limitations and precautions.” The company said it did not have information about the CDPHE’s transition plan.

“While we are disappointed with the Colorado Department of Public Health and Environment’s decision to no longer use Curative for testing at Colorado long term care facilities, we continue to be confident in our data, our test, and in the service we continue to provide to hundreds of thousands of patients every day,” the company said in the statement. “Curative’s test performance and labeling have not changed, nor has the company observed any changes in test performance. Patient health and safety is Curative’s number one concern and we will be working to make sure there is a safe and smooth transition for the patients we’ve been serving in Colorado. Curative remains committed to providing reliable, convenient, and painless COVID-19 testing for those who need it.”