Colorado Department of Public Health and Environment (CDPHE) will no longer be using Curative testing effective, today, Jan. 21 in residential care facilities — as well as in correctional facilities, homeless shelters, and other congregate settings. The decision comes after the FDA cited additional concerns about the accuracy of the Curative assay and collection methods.
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. If an individual is asymptomatic, we advise that they seek testing at a non-Curative site. The state does expect it will transition away from Curative testing at community testing sites, as well, in the coming weeks. In the interim, people who got tested at a Curative site on or after 1/13/2021 with an oral swab and received negative results should be retested using an anterior nares swab.
CDPHE announced on Jan. 12 that it was closely monitoring the Curative testing administration in Colorado, after the Food and Drug Administration (FDA) first issued a safety alert about the potential risk of false-negative results for the tests. After monitoring closely and getting additional guidance from FDA earlier this week, the state made the decision to cease testing in congregate settings immediately.
Nearly 1,000 congregate facilities are affected by the decision. Curative recently averaged about 70,000 tests per week during its contract with the state which started in November.
“We are committed to providing all Coloradans with access to reliable tests,” said Sarah Tuneberg, testing and containment manager for the 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.”
CDPHE is in close contact with residential care facilities and others affected by the change. Learn more about the transition away from Curative through our FAQ.