Verification and Validation of SARS-CoV-2 Assay Performance on the Abbott m 2000 and Alinity m Systems-Reference-Cited by-同舟云学术

Verification and Validation of SARS-CoV-2 Assay Performance on the Abbott m 2000 and Alinity m Systems

Published:2021-04-20 Issue:5 Volume:59 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Hirschhorn Julie W.¹,Kegl April¹,Dickerson Tanisha¹,Glen W. Bailey¹,Xu Gang¹,Alden Jay¹,Nolte Frederick S.¹^ORCID

Affiliation:

1. Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina, USA

Abstract

We verified the analytical performance of the Abbott RealTi m e SARS-CoV-2 assay on the m 2000 system and compared its clinical performance to the CDC 2019-nCoV real-time PCR diagnostic panel and the Thermo Fisher TaqPath RT-PCR COVID-19 kit. We also performed a bridging study comparing the RealTi m e SARS-CoV-2 assay with the new Abbott Alinity m SARS-CoV-2 assay.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.03119-20

Reference14 articles.

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3. FDA. 2020. In vitro diagnostic EUAs. U.S. Food and Drug Administration Bethesda MD. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas. Accessed 3 November 2020.

4. CDC. 2019. Novel coronavirus (2019-nCoV) real-time RT-PCR diagnostic panel (EUA). Instructions for use: package insert. Centers for Disease Control and Prevention Atlanta GA.

5. Thermo Fisher. 2019. TaqPath™ COVID-19 Combo kit and TaqPath™ (EUA). Instructions for use: package insert. Thermo Fisher Waltham MA.

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