Colorado’s health department is closely monitoring a COVID-19 test used at many nursing homes after the FDA issued a safety alert about the potential risk of false-negative results.
The Curative COVID-19 test is used at Columbine Health Systems and could be a possible explanation for the virus’ dramatic increase at its North Shore Health and Rehabilitation Center in Loveland last week.
Colorado Department of Public Health and Environment looked but found no evidence of the highly contagious U.K. coronavirus variant at North Shore Health after cases jumped from 38 to 110 in a matter of days.
A high percentage of false negative tests could explain how the virus took hold of so many of North Shore’s staff within a short window of time.
“We need to trust our tests,” said Yvonne Myers, director of health systems for Columbine Health. “If we have a lot of false negatives, we could have asymptomatic people working who are spreading the virus.
“For 11 months we’ve been doing all the protocols, all the things we’re supposed to do, so why” was the increase so great? Myers asked. The variant, had it been present, could have been one answer. “Do you want the variant? Probably not,” Myers said. “But is the testing right?”
The state, which pays for the testing at Columbine Health Systems and many other nursing homes throughout Colorado, requires them to use the Curative COVID-19 test, which got FDA approval under emergency use authorization.
On Tuesday, CDPHE issued a statement to the Coloradoan saying: “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.”
The statement said CDPHE has thoroughly reviewed the FDA Emergency Use Authorization safety statement and data from Curative tests performed in Colorado. It believes the tests are a “reliable option.”
Curative tests are also used at testing sites throughout Colorado, including at Denver International Airport and three sites in Weld County, among others.
Neither the FDA nor the state health department said what percentage of tests resulted in false negatives or why they are negative, but the FDA appeared to blame those taking samples for the false negative results.
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. 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.”
CDPHE has also requested Curative provide a full instructional video on the proper way to collect a sample to train or retrain administers.
It said in its statement it will continue to monitor the situation as it evolves.
The FDA alert suggests retesting patients using a different test if inaccurate results were given by the Curative SARS-Cov-2 test.
In the wake of the report, Los Angeles County discontinued use of the Curative COVID-19 PCR tests. Curative is a Los Angeles-based company, which formed a year ago to concentrate on fighting sepsis but changed its focus to COVID-19, according to published reports.
“We don’t have another place to test,” Myers said. If it goes to another lab, like the one at Colorado State University, Columbine would have to pay for the tests.
The good news for North Shore is that all residents and staff who wanted the vaccine have been vaccinated as of Monday, Myers said. Next week, the nursing home will start on the second booster.
Pat Ferrier is a senior reporter covering business, health care and growth issues in Northern Colorado. Contact her at email@example.com. Please support her work and that of other Coloradoan journalists by purchasing a subscription today.