Independent Clinical Study Confirms Cue Health’s COVID-19 Test Is As Accurate As a Lab Test
Detroit, Michigan
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October 20, 2023 09:00 AM Eastern Daylight Time
By Rachael Green, Benzinga
A new study published in Microbiology Spectrum put Cue Health’s (NASDAQ: HLTH) COVID-19 test head-to-head with lab-based PCR tests, which have become the gold standard in diagnostic accuracy for the virus — and found that, when used at the point-of-care, the Cue COVID-19 Test demonstrated 99.4% accuracy compared to the lab tests. The independent study serves as yet another major validation for the COVID-19 test, which officially became the first to receive De Novo authorization from the FDA for home use this past June.
Study Confirms Cue COVID-19 Test Is As Accurate As PCR Test, As Fast As Rapid Antigen Test
The peer-reviewed study was the largest of its kind on asymptomatic people, comparing the Cue COVID-19 Test to a lab-based PCR in over 3,000 patients at multiple clinical sites, the majority of whom were not showing any symptoms of COVID.
Across that wide sample base the reported overall accuracy rate was 99.4%. Moreover, while a lab-based test can take hours or days to deliver results, the entire diagnostic process using Cue’s platform took just 25 minutes, including the time spent collecting the sample.
Typically, that kind of speed comes with a tradeoff in accuracy. While PCR lab tests are the gold standard in accuracy, rapid antigen tests – which are less sensitive than PCR tests but easier to use – have been the gold standard in speed and ease of use. Antigen tests can deliver results in as little as 15 minutes, but they only have an accuracy rate of about 80% overall and among people not currently showing symptoms, that accuracy drops even lower to just 39%, according to at least one study
Because of this lower accuracy, users are typically advised to take another test a couple of days after receiving a negative result from an antigen test to make sure they really don’t have COVID. That couple of days could not only delay the time to treatment but it also creates a window of time where the person could unknowingly infect others if they do, in fact, have COVID.
So the at-home available Cue test, which makes it so easy to collect and test samples that anyone can do it without special training, is able to merge the accuracy of a lab PCR test with the speed and simplicity of an at-home rapid antigen test.
At clinics and hospitals, the portable Cue Reader and COVID-19 test cartridges and swab require no special training to use and can deliver results in 20 minutes. Instead of scheduling a lab test and waiting days for the results, healthcare providers can get a diagnosis right away and send the patient home with the right prescription and treatment plan rather than waiting days to hear back about lab results.
At home, consumers can skip the point-of-care visit altogether and instead get a Cue Reader and a stash of COVID-19 test cartridges to keep at home. Whenever they think they might have been exposed, they can take a simple-to-use test at home and get the result in 20 minutes. After that, they can connect with a healthcare provider right from the Cue Health App to discuss the result, come up with a treatment plan and have any necessary prescriptions delivered right to their doorstep.
“Narrowing the time interval from test to treatment accelerates how quickly the patient can begin convalescence and return to work, which reduces overall economic stress,” the researchers wrote in the study, adding that this “has particular benefit to at-risk communities where other health and community resources, including testing, can be limited.”
The researchers also noted that the high accuracy, especially the lack of false negatives, means Cue’s test could help curb the spread of COVID. People can get reliable results even before they start showing symptoms and begin isolation, masking, and other best practices for avoiding passing the infection on to others — a crucial factor missing from antigen tests.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
The Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (Cue COVID-19 Test) and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use have not been FDA cleared or approved, but they have been authorized by FDA under an Emergency Use Authorization. These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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