eClinical Technology and Industy News

Cue Health’s Connected Point-of-Care COVID-19 Test Demonstrates 97.8% Agreement When Compared to Central Lab PCR Testing in an Independent Clinical Validation Study

Excerpt from the Press Release:

SAN DIEGO, Feb. 11, 2021 /PRNewswire/ — Cue Health Inc. (Cue) announced today the results of an independent clinical validation study conducted by Mayo Clinic Laboratories evaluating the accuracy of Cue’s COVID-19 Test in the point-of-care setting against the centralized lab PCR testing model. The study, which was published in Diagnostic Microbiology and Infectious Diseases, included samples from 292 patients at a collection site operated by the Mayo Clinic Health System. The study found that the overall concordance between the Cue point-of-care test and the reference laboratory tests was 97.8%.  This is one of the only real-world clinical evaluations to date to compare the accuracy of molecular point-of-care and gold-standard central laboratory tests using samples obtained prospectively from patients, and not using archived or previously tested specimens.

“This study demonstrates the value and accuracy of Cue’s COVID-19 Test as a solution for fast, accurate, molecular testing at point-of-care,” said Ayub Khattak, Founder & CEO of Cue. “A study of this size and scope validates that it is possible to have the accuracy of the best central lab tests with the ease-of-use and speed of a point-of-care test. With many tests coming onto the market, a real-world, independent clinical study like this is valuable to help inform the public and healthcare practitioners about the performance and value of new technologies, and tests for helping to manage the COVID-19 pandemic,” Khattak added.

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