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

Author:

Zhen Wei1,Smith Elizabeth1,Manji Ryhana1,Schron Deborah2,Berry Gregory J.12

Affiliation:

1. Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA

2. Department of Pathology and Laboratory Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, USA

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 e mergency u se a uthorization (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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference12 articles.

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3. 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#/bda7594740fd40299423467b48e9ecf6. Accessed 15 April 2020.

4. 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-mission-on-covid-19-final-report.pdf. Accessed 15 April 2020.

5. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1

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