Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA-Reference-Cited by-同舟云学术

Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA

Published:2020-07-23 Issue:8 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Mitchell Stephanie L.¹,St. George Kirsten²^ORCID,Rhoads Daniel D.³,Butler-Wu Susan M.⁴,Dharmarha Vaishali⁵,McNult Peggy⁵,Miller Melissa B.⁶

Affiliation:

1. Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA

2. Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, New York, USA

3. University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA

4. Department of Pathology, Keck School of Medicine of USC, Los Angeles, California, USA

5. American Society for Microbiology, Washington, DC, USA

6. University of North Carolina School of Medicine, Department of Pathology and Laboratory Medicine, Chapel Hill, North Carolina, USA

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the majority of clinical microbiology laboratories are dependent on commercially available SARS-CoV-2 molecular assays.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.00796-20

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