DENVER – As of Thursday, Colorado will no longer use COVID-19 curative tests in residential care facilities, correctional facilities, shelters, and other congregational care facilities following further warnings from the U.S. Food and Drug Administration about false negatives with the tests and problems with the tests assay.
The Colorado Department of Public Health and Environment said nearly 1,000 of these types of facilities had used the tests in the past three months, and about 70,000 curative tests per week had been conducted in the state since the contract with the state went online in early November. .
The state said there were 715,619 curative tests performed in Colorado on Jan. 19.
Dee CDPHE said it would discontinue use of the test in municipal facilities after a January 12 warning that it was “closely monitoring” the curative test and its administration to humans.
That message came after the FDA issued a safety warning that day about false negatives in the test and incorrect 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, believed the tests would still be “a reliable option in the context of FDA guidelines.”
But the department said further concerns from the FDA prompted them to announce the decision Thursday.
The latest warning from the FDA on 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 the Sample collection is supervised; and if an oral test gives a negative result, it must be confirmed by another method.
In addition to using the tests in some municipal health facilities, the state has also used curative tests at several mobile and drive-through community test sites set up in the state with local public health departments, including some larger locations at Denver International Airport, the Jefferson County Fairgrounds and the University of Northern Colorado – all of which were still in operation this month.
The CDPHE said on Thursday that it plans to stop using curative tests on community testing sites in the coming weeks. The department advises people who have been tested in curative sites on January 13 or after with an oral swab who received negative results to be retested with an anterior nasal gauze pad.
The CDPHE said sites that are still using curative tests in the meantime should only use them for symptomatic people with anterior nostrils or nasopharyngeal swabs and not for oral swabs. It advises asymptomatic people to get tested at a non-curative site.
“We are committed to giving all Coloradans access to reliable testing,” said Sarah Tuneberg, the testing and containment manager for the state’s COVID-19 response. “Clearly, with the latest FDA guidelines, we need to move away from using curative testing in community facilities. We have a transition plan that allows us to move quickly with minimal disruption to testing, which is a critical tool to slow the spread of COVID-19. We remind Coloradans that testing, while crucial, is just one tool in our toolbox. We should all continue to follow public health protocols, such as wearing a mask, avoiding large gatherings, and taking physical distance. “
The state said it had “no evidence” that Colorado was seeing “extremely inaccurate results” because of the curative tests and was unaware of cases where false negatives led to more outbreaks in municipal health facilities.
Other community testing sites that were active in January that have used Curative testing 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 that it would no longer offer curative testing and that the Jeffco Fairgrounds site and the Curative Mobile Vans in Conifer and Evergreen would be temporarily closed before reopening in conjunction with the CDPHE’s Rapid Response Team .
JCPH said the Jeffco Fairgrounds site would reopen on Saturday and the Conifer and Evergreen test sites would reopen according to their normal Wednesday and Sunday schedules.
“Testing for COVID-19 remains one of the most important tools to combat the virus, and JCPH is committed to ensuring that 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 that the test disruption caused by this change is minimal.”
The CDPHE said it worked with its contracts and tax teams, as well as with the Colorado Attorney General’s Office, to “ensure that changes to or termination of the contract with Curative are not a cost borne by Colorado taxpayers.”
Curative said in a statement that it was working with the FDA to address the departments’ concerns and provide them with more data to “address these limitations and precautions.” The company said it had no 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 in long-term care settings in Colorado, we remain confident in our data, our testing, and the service we continue to provide. hundreds of thousands of patients every day, ”the company said in the statement. “Curative’s testing performance and labeling has not changed, nor has the company observed changes in testing performance. Patient health and safety is Curative’s primary concern and we will work to ensure there is a safe and smooth transition for the patients we have served in Colorado. Curative remains committed to providing reliable, convenient, and painless COVID-19 testing for those who need it. “