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. 2021 May;100(1):115307.
doi: 10.1016/j.diagmicrobio.2020.115307. Epub 2021 Jan 6.

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  1 , Vipul A Trivedi  2 , Angie M Stransky  3 , Artika Misra  3 , Bobbi S Pritt  1 , Matthew J Binnicker  1 , Brad S Karon  4
Affiliations

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 et al. Diagn Microbiol Infect Dis. 2021 May.

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.

Keywords: Coronavirus disease 2019; Nucleic acid amplification test; Point of care; Severe acute respiratory syndrome coronavirus 2.

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References

    1. Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, et al. Performance of Abbott ID now COVID-19 rapid nucleic acid amplification test using nasopharyngeal swabs transported in viral transport media and dry nasal swabs in a New York City Academic Institution. J Clin Microbiol. 2020;58 e01136–20. - PMC - PubMed
    1. Creager HM, Cabrera B, Schnaubelt A, Cox JL, Cushman-Vokoun AM, Shakir SM, et al. Clinical evaluation of the BioFire(R) respiratory panel 2.1 and detection of SARS-CoV-2. J Clin Virol. 2020;129 - PMC - PubMed
    1. Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, et al. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the lombardy region, Italy. JAMA. 2020;323:1574–1581. - PMC - PubMed
    1. Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382:1708–1720. - PMC - PubMed
    1. Hogan CA, Garamani N, Lee AS, Tung JK, Sahoo MK, Huang C, et al. Comparison of the accula SARS-CoV-2 Test with a laboratory-developed assay for detection of SARS-CoV-2 RNA in clinical nasopharyngeal specimens. J Clin Microbiol. 2020;58 e01072–20. - PMC - PubMed

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