DENVER – As of Thursday, Colorado will no longer use the COVID-19 curative tests at residential care institutions, correctional institutions, shelters and other congregated care locations, after further warnings from the U.S. Food and Drug Administration about false negatives with the tests and problems with the tests.
The Colorado Department of Public Health and Environment said that nearly 1,000 facilities of this type have used the tests in the past three months and that about 70,000 curative tests per week have been done in the state since its contract with the state went online in early November. .
The state said 715,619 curative tests were carried out in Colorado on January 19.
Thee CDPHE said he would stop using the test at the assembled facilities after notifying on January 12 that he was “closely monitoring” the curative test and its administration to people.
This warning came after the FDA issued a security alert that day warning of false negatives with the test and inadequate administration of the test by some suppliers. The CDPHE said at the time that the Dressing test, which received an Emergency Use Authorization from the FDA, believed that the tests would still be “a reliable option in the context of FDA guidelines”.
But the department said other concerns from the FDA prompted them to make the decision announced on Thursday.
The latest FDA alert on curative tests says they should only be used under three conditions: if the person is symptomatic and within 14 days of the onset of symptoms; if sample collection is supervised; and when an oral test gives a negative reading, it must be confirmed with a different method.
In addition to using tests at some congregated health centers, the state has also used curative tests at several mobile and drive-through testing sites created across 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 still in operation this month.
CDPHE said on Thursday that it plans to stop using curative tests at community testing sites in the coming weeks as well. The department is advising people who were tested in healing centers on January 13 or later with an oral swab that received negative results to be tested again with an anterior nostril swab.
The CDPHE said that sites that still use curative tests, however, should only use them on symptomatic people with previous nostrils or nasopharyngeal swabs and not oral swabs. It is advising people who are asymptomatic to get tested on a non-healing site.
“We are committed to providing all Colorado residents with access to reliable testing,” said Sarah Tuneberg, test and containment manager for the state’s COVID-19 response. “It is clear that, with the latest guidance from the FDA, we need to stop using curative testing in congregated facilities. We have a transition plan that will allow us to move quickly with minimal disruption to testing, which is a critical tool for slowing the spread of COVID-19. We remind Coloradans that testing, while critical, is only a tool in our toolbox. We all need to continue to follow public health protocols, such as wearing masks, avoiding large meetings and physical distance.
The state said it had “no evidence” that Colorado saw “excessively inaccurate results” because of the curative tests and that it was not aware of any cases where false negatives would lead to further outbreaks in congregated health centers.
Other community test sites operating in January that have used 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 on Thursday afternoon that it would no longer offer curative tests and that the Jeffco Fairgrounds website and the Curative Mobile Vans in Conifer and Evergreen would be temporarily closed before reopening in partnership with the CDPHE Rapid Response Team.
JCPH said the Jeffco Fairgrounds website would reopen on Saturday and the test sites for Conifer and Evergreen would reopen at their normal Wednesday and Sunday hours.
“Testing for COVID-19 remains one of the most important tools to fight the virus, and JCPH is committed to ensuring that accurate and reliable testing is widely available to our residents,” said Christine Billings, manager of the Response Office. to the JCPH Pandemic. “We want to assure residents that there will be a minimum of interruption in testing as a result of this change.”
CDPHE said it is working with its contracts and tax teams, as well as with the Colorado Attorney General’s Office, to “ensure that changes 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 departmental concerns and provide them with more data to “address these limitations and precautions”. The company said it had no information about CDPHE’s transition plan.
“Although we are disappointed in the decision by the Colorado Department of Public Health and Environment to no longer use Curative for testing at Colorado’s long-term care facilities, we remain confident in our data, our testing and the service we continue to provide to hundreds of thousands of patients every day, ”said the company in the statement. “Curative’s test performance and labeling have not changed, nor has the company seen any change in test performance. Patient health and safety is Curative’s number one concern and we will work to ensure that there is a safe and smooth transition for the patients we serve in Colorado. Curative remains committed to providing reliable, convenient and painless COVID-19 tests to those in need. “