HLTH - Independent Clinical Study Confirms Cue Health's COVID-19 Test Is As Accurate As A Lab Test | 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. ...