Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection-Reference-Cited by-同舟云学术

Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection

Published:2020-09-22 Issue:10 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Pham Jimmykim¹,Meyer Sarah¹,Nguyen Catherine¹,Williams Analee¹,Hunsicker Melissa¹,McHardy Ian²,Gendlina Inessa³,Goldstein D. Yitzchak³,Fox Amy S.³,Hudson Angela¹,Darby Paul¹,Hovey Paul¹,Morales Jose¹,Mitchell James¹,Harrington Karen¹,Majlessi Mehrdad¹,Moberly Joshua¹,Shah Ankur¹,Worlock Andrew¹,Walcher Marion¹,Eaton Barbara¹,Getman Damon¹^ORCID,Clark Craig¹

Affiliation:

1. Hologic, Inc., San Diego California, USA

2. Scripps Health, Microbiology Laboratory, San Diego California, USA

3. Montefiore Medical Center, Department of Pathology, Bronx, New York, USA

Abstract

The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome.

Funder

Hologic

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01669-20

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