Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucleic acid amplification) test at a community drive through collection center

Leslie J. Donato, Vipul A. Trivedi, Angie M. Stransky, Artika Misra, Bobbi S. Pritt, Matthew J. Binnicker, Brad S. Karon

Research output: Contribution to journalArticlepeer-review

Abstract

Point-of-care (POC) tests are in high demand in order to facilitate rapid care decisions for patients suspected of SARS-CoV-2. We conducted a clinical validation study of the Cue Health POC nucleic acid amplification test (NAAT) using the Cue lower nasal swab, compared to a reference NAAT using standard nasopharyngeal swab, in 292 symptomatic and asymptomatic outpatients for SARS-CoV-2 detection in a community drive through collection setting. Positive percent agreement between Cue COVID-19 and reference SARS-CoV-2 test was 91.7% (22 of 24); or 95.7% (22 of 23) when one patient with no tie-breaker method was excluded. Negative percent agreement was 98.4% (239 of 243), and there were 25 (8.6%) invalid or canceled results. The Cue COVID-19 test demonstrated very good positive and negative percent agreement with central laboratory tests and will be useful in settings where accurate POC testing is needed to facilitate management of patients suspected of COVID-19.

Original languageEnglish (US)
Article number115307
JournalDiagnostic Microbiology and Infectious Disease
Volume100
Issue number1
DOIs
StatePublished - May 2021

Keywords

  • Coronavirus disease 2019
  • Nucleic acid amplification test
  • Point of care
  • Severe acute respiratory syndrome coronavirus 2

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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