Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2020 Jul 23;58(8):e00783-20.
doi: 10.1128/JCM.00783-20. Print 2020 Jul 23.

Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2

Wei Zhen #  1 , Elizabeth Smith #  1 , Ryhana Manji  1 , Deborah Schron  2 , Gregory J Berry  3   2
Affiliations
Comparative Study

Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2

Wei Zhen et al. J Clin Microbiol. .

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.

Keywords: COVID-19; EUA; SARS-CoV-2; molecular diagnostics; nasopharyngeal; near-patient testing.

PubMed Disclaimer

References

    1. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. 2020. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol 5:536–544. doi: 10.1038/s41564-020-0695-z. - DOI - PMC - PubMed
    1. CDC. 2020. Locations with confirmed COVID-19 cases, global map. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov. Accessed 15 April 2020.
    1. Center for Systems Science and Engineering. 2020. COVID-19 dashboard by the Center for Systems Science and Engineering at Johns Hopkins University. https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594.... Accessed 15 April 2020.
    1. WHO-China Joint Mission on Coronavirus Disease. 2020. Report of the WHO-China Joint Mission on Coronavirus Disease. https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mis.... Accessed 15 April 2020.
    1. van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. 2020. Aerosol and surface stability of SARS-CoV-2 compared to SARS-CoV-1. N Engl J Med 382:1564–1567. doi: 10.1056/NEJMc2004973. - DOI - PMC - PubMed

MeSH terms