Local health officials are standing behind the widely used Curative COVID-19 tests being administered at various sites in the valley, despite a warning by the U.S. Food and Drug Administration this month that the test has a risk of false negative results.
The Colorado Department of Public Health and Environment also is supporting the use of Curative in the state’s communities, while closely monitoring and evaluating the test’s effectiveness.
The support of Curative is based on the FDA’s lack of data or evidence that there is a higher risk of false negative results over other testing methods, according to Alyssa Franklin, director of Aspen Valley Hospital’s primary care department, who also is in charge of the hospital’s respiratory center and two free testing sites, one in Aspen behind City Hall and the other in Basalt.
Carly Senst, Pitkin County’s testing and vaccine coordinator, agreed that the FDA’s safety statement issued earlier this month was intentionally vague since data and conditions are constantly changing.
“I’m glad CDPHE is supportive of Curative and is continuing to monitor it,” she said. “I wish (FDA) had accompanying data.”
She noted that the storing and administering may be part of what the FDA is being overly cautious about, but Senst assured the public that the Pitkin County Health Department is following protocols to the letter.
“Everyone is doing their best with the information coming in,” Senst said, noting that there is no differentiation of the efficacy in the two biggest methods of testing in Pitkin County.
The other test being used locally is administered by Dr. Brooke Allen of Roaring Fork Neurology, P.C. and Mountain Neurological Research Center.
She runs six sites that offer free tests to Roaring Fork Valley residents, averaging around 2,000 a week. Those are MicrogenDx saliva PCR tests, which detect all variants of the virus, Allen said via email Wednesday.
She declined to comment on the Curative situation because she hasn’t see the data that supports the FDA alert.
The Aspen School District is using Curative testing for its students and teachers.
David Baugh, superintendent of schools, sent an email Monday supporting the continued use of Curative tests, and said the FDA alert reiterates that there is a risk of false negatives with the Curative test if sample collection is done improperly.
“This was a reminder to follow the sample collection procedures carefully, and that false negatives are always possible with any lab test,” he wrote in the email. “There is nothing specific to the Curative test to indicate that it is more likely to generate false negative results than any other RT-PCR test.”
The Curative test is self-administered at the kiosk behind City Hall. When a person gets an appointment confirmation, there are instructions via video on how to property swab the mouth and place it in the specimen tube.
Franklin pointed out since all COVID tests have a certain rate of false negative results, people should still follow all COVID safety protocols and public health orders.
“A test doesn’t change our behavior,” she said.
As of Wednesday, 4,840 tests have been conducted at the Aspen site. Of those, 12% have tested positive, and 70% have been asymptomatic.
CDPHE has reviewed the FDA safety statement and data resulting from Curative tests performed in Colorado, according to a news release.
The state agency believes 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,” said Sarah Tuneberg, COVID-19 Innovation Response Team Lead and Senior COVID-19 Advisor at CDPHE. “Each type of test is appropriate for specific situations. We will continue to evaluate the test’s effectiveness and will make decisions accordingly.”
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January 14, 2021 at 12:20PM
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Local officials stand behind Curative's COVID-19 test efficacy - Aspen Times
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