Skip to main content
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems
  • Log in
  • My alerts
  • My Cart

Main menu

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems

User menu

  • Log in
  • My alerts
  • My Cart

Search

  • Advanced search
Journal of Clinical Microbiology
publisher-logosite-logo

Advanced Search

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
Special Issue Virology

Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens

Wei Zhen, Ryhana Manji, Elizabeth Smith, Gregory J. Berry
Alexander J. McAdam, Editor
Wei Zhen
aInfectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ryhana Manji
aInfectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Elizabeth Smith
aInfectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gregory J. Berry
aInfectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA
bDepartment of Pathology and Laboratory Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alexander J. McAdam
Boston Children's Hospital
Roles: Editor
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
DOI: 10.1128/JCM.00743-20
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Article Figures & Data

Tables

  • TABLE 1

    Overview of four molecular in vitro diagnostic EUA assays used in this studya

    TABLE 1
    • ↵a BAL, bronchoalveolar lavage; NPS, nasopharyngeal swabs; NS, nasal swabs; OPS, oropharyngeal swabs; TCID50, 50% tissue culture infective dose.

  • TABLE 2

    Summary of limit of detection results

    TABLE 2
    • ↵a The limit of detection by positive rate for each assay is highlighted in bold.

    • ↵b 95% CI, upper/lower (±) 95% confidence interval.

    • ↵c The final LoD data were determined on the basis of each manufacturer’s results interpretation algorithm.

    • ↵d NA, not applicable.

  • TABLE 3

    Clinical performance comparison of four EUA molecular assays for the detection of SARS-CoV-2 in nasopharyngeal swab specimens (n = 104)

    TABLE 3
    • ↵a The reference standard was defined as the result obtained from at least 3 of the 4 molecular assays.

    • ↵b Kappa values representing levels of agreement are categorized as follows: >0.90, almost perfect; 0.80 to 0.90, strong; 0.60 to 0.79, moderate; 0.40 to 0.59, weak; 0.21 to 0.39, minimal; (0 to 0.20), none.

    • ↵c ± 95% CI, upper/lower 95% confidence interval.

    • ↵d This one sample had cycle threshold (CT) values of 38.9 and 39.6 for N1 and N2, respectively, by the CDC assay.

    • ↵e Cycle threshold (CT) value undetermined.

    • ↵f These two samples had cycle threshold (CT) values of 36.2 and 38.5 by the Hologic assay.

  • TABLE 4

    Details of discordant sample analysis

    TABLE 4
    • ↵a Discordant sample results are highlighted in bold. CT, cycle threshold; ID, identifier; NEG, negative; POS, positive.

  • TABLE 5

    Throughput and workflow evaluation for four EUA molecular SARS-CoV-2 assays

    TABLE 5
    • ↵a NA, not applicable.

PreviousNext
Back to top
Download PDF
Citation Tools
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
Wei Zhen, Ryhana Manji, Elizabeth Smith, Gregory J. Berry
Journal of Clinical Microbiology Jul 2020, 58 (8) e00743-20; DOI: 10.1128/JCM.00743-20

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Print

Alerts
Sign In to Email Alerts with your Email Address
Email

Thank you for sharing this Journal of Clinical Microbiology article.

NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses.

Enter multiple addresses on separate lines or separate them with commas.
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
(Your Name) has forwarded a page to you from Journal of Clinical Microbiology
(Your Name) thought you would be interested in this article in Journal of Clinical Microbiology.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Share
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
Wei Zhen, Ryhana Manji, Elizabeth Smith, Gregory J. Berry
Journal of Clinical Microbiology Jul 2020, 58 (8) e00743-20; DOI: 10.1128/JCM.00743-20
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Top
  • Article
    • ABSTRACT
    • INTRODUCTION
    • MATERIALS AND METHODS
    • RESULTS
    • DISCUSSION
    • ACKNOWLEDGMENTS
    • FOOTNOTES
    • REFERENCES
  • Figures & Data
  • Info & Metrics
  • PDF

KEYWORDS

COVID-19
EUA
molecular diagnostics
nasopharyngeal
real-time RT-PCR
SARS-CoV-2

Related Articles

Cited By...

About

  • About JCM
  • Editor in Chief
  • Board of Editors
  • Editor Conflicts of Interest
  • For Reviewers
  • For the Media
  • For Librarians
  • For Advertisers
  • Alerts
  • RSS
  • FAQ
  • Permissions
  • Journal Announcements

Authors

  • ASM Author Center
  • Submit a Manuscript
  • Article Types
  • Resources for Clinical Microbiologists
  • Ethics
  • Contact Us

Follow #JClinMicro

@ASMicrobiology

       

ASM Journals

ASM journals are the most prominent publications in the field, delivering up-to-date and authoritative coverage of both basic and clinical microbiology.

About ASM | Contact Us | Press Room

 

ASM is a member of

Scientific Society Publisher Alliance

 

American Society for Microbiology
1752 N St. NW
Washington, DC 20036
Phone: (202) 737-3600

 

Copyright © 2021 American Society for Microbiology | Privacy Policy | Website feedback

Print ISSN: 0095-1137; Online ISSN: 1098-660X