Independent study shows Cue Health’s molecular COVID-19 test accuracy compared to a lab-based PCR test

Aug. 22, 2022
In clinical study on asymptomatic people, Cue demonstrated 99.4% accuracy compared to lab-based PCR.

Cue Health Inc. announced the preprint publication of an independent clinical study on asymptomatic people - demonstrating that its point of care (POC) molecular COVID-19 test, which produces results in approximately 20 minutes, is as accurate as a centralized lab-based RT-PCR.

The study presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals. The findings revealed a 99.4% match between results from Cue’s test and the reference PCR tests, including 100% clinical sensitivity to detect positive cases, yielding no false negatives. Of this testing population, 98.7% was asymptomatic at varying stages of infection and viral load.

Dr. Anu Rebbapragada, D(ABMM) FCCM and Laboratory Director at FH Health, who was responsible for diagnostic testing and the analysis of results for this manuscript.further noted in the paper that due to its high sensitivity and quick turnaround time for results (approximately 20 minutes), screening programs utilizing Cue’s COVID-19 test can:

  • Reduce the likelihood of spread in gatherings, including workplace settings, providing confidence when testing asymptomatic individuals;
  • Facilitate earlier access to treatment, promoting timely clinical management and intervention with antivirals;
  • Maintain cost-effectiveness and efficiency by avoiding the logistics and infrastructure needed for lab-based PCR tests and the frequent re-screening needed with lower sensitivity antigen tests.

Cue Health release