Cue Health announced the preprint publication of an independent clinical study demonstrating that its point of care (POC) molecular COVID 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. 

“Rapid and accurate COVID-19 asymptomatic screening has been challenging due to the poor sensitivity of antigen testing and the delays with lab-based PCR testing,” says Anu Rebbapragada, PhD, D(ABMM) FCCM and Laboratory Director at FH Health, who was responsible for diagnostic testing and the analysis of results for this manuscript. “The findings from our large study indicate that sensitivity of Cue’s POC testing may be an excellent proxy for PCR when accurate and fast results are urgently needed to curb transmission.”

Rebbapragada 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.

“We’re proud of the results of this study, which further validates that with Cue, you can achieve diagnostic testing that is accurate, fast, and convenient,” says Andy Hudak, VP of research & development and program management at Cue Health. “As the study demonstrates, the high sensitivity of Cue’s testing platform can quickly identify asymptomatic cases allowing for large groups, such as in the workplace, to gather safely.”

The FH Health analysis included results from 13,848 individuals who accessed the private (fee for service) COVID-19 Express Testing Services at seven FH Health clinics located in urban centers in Ontario, Canada between July 17, 2021 and Jan. 31, 2022.

The diverse testing population ranged in age from infants to seniors. Specimen collection and Cue COVID-19 testing was performed by trained registered nurses (RNs and RPNs) at FH Health clinic sites. RT-PCR was performed at the FH Health Laboratory, which is licensed by the Ontario Ministry of Health and accredited under ISO 15189 for COVID-19 diagnostic testing. Cue did not provide funding or any other support of the FH Health Study.

Cue’s COVID-19 test has been authorized for use in the United States by FDA under Emergency Use Authorizations (EUA) for professional use at the point-of-care by healthcare providers and certified laboratories as well as for over-the-counter use. It is also authorized for use in Canada through Interim Order authorization from Health Canada.