CDPHE to closely monitor Curative testing and add measures to ensure efficacy

Colorado Department of Public Health and Environment is closely monitoring the Curative testing administration in Colorado, after the Food and Drug Administration (FDA) issued a safety alert about the potential risk of false-negative results for the tests. To be responsive to the alert and help ensure testing viability, CDPHE has also requested Curative provide a full instructional video on the proper way to collect a sample to train or retrain administers. 

According to the FDA: “To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers. When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate.”

Read the entire safety statement on the FDA website, which describes appropriate use. CDPHE will continue to monitor the situation as it evolves. 

CDPHE has thoroughly reviewed the FDA Emergency Use Authorization (EUA), safety statement, and data resulting from Curative tests performed in Colorado. The state believes that tests processed by Curative are a reliable option in the context of FDA guidance, as existing oversight and strict instructions related to the sampling process increase the likelihood that the results of the test are more accurate.

“At this time, we believe these Curative tests are one more tool in our COVID-19 testing toolbox. Each type of test is appropriate for specific situations. We will continue to evaluate the test’s effectiveness and will make decisions accordingly,” said Sarah Tuneberg, COVID-19 Innovation Response Team Lead and Senior COVID-19 Advisor at CDPHE.  

At the request of some local partners, CDPHE is supporting mobile test sites, long-term testing sites, and pop-up community testing events to ensure everyone has access to COVID-19 tests. The state will continue to work with local partners to meet community testing needs in a manner that best serves their residents. 

While testing is an important tool in the COVID-19 response, the state cautions that a negative test doesn’t mean it’s OK to meet in large gatherings or bypass other public health protocols, like wearing a mask. All Coloradans need to mask up, physically distance, interact only with members of their own households, and stay home while sick.

Curative has been working with the FDA to address concerns, including the testing limitations. The FDA validated Curative’s test during the pandemic under an Emergency Use Authorization. It is labeled with specific warnings, precautions, and limitations that the FDA reiterated in the safety communication. 

Current Curative testing sites in Colorado are:

Site(s)CountyType
DIA – Denver International AirportDenverPrivate Kiosk
Jefferson County FairgroundsJeffersonDrive-thru
University of Northern ColoradoWeldKiosk
Youth Sports Fields – GreeleyWeldDrive-thru
Bailey Public LibraryParkMobile Van
Our Lady of the Pines Catholic ChurchJeffersonMobile Van
Clear Creek County EMSClear CreekMobile Van
Sterling Center DouglasMobile Van
Larkspur Town Hall DouglasMobile Van
Buchanan Recreation Center JeffersonMobile Van
Logan County FairgroundsLoganMobile Van
Washington County FairgroundsWashingtonMobile Van
Sedgwick County FairgroundsSedgwickMobile Van
Morgan Community College (both locations)Morgan and YumaMobile Van
Wiggins Community ChurchWeldMobile Van
Elk Creek Elementary SchoolGarfieldMobile Van
Bea Underwood Elementary School GarfieldMobile Van
Garfield County FairgroundsGarfieldMobile Van
Montrose Recreation Center – Field HouseMontroseMobile Van
Bill Heddles Recreation Center – Field HouseDeltaMobile Van
Delta County FairgroundsDeltaMobile Van

*Please go to curative.com for testing site hours* 

For any patient inquiries related to their test they may contact support@curative.com or 888-702-9042.

CDPHE to closely monitor Curative testing and add measures to ensure efficacy