Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens-Reference-Cited by-全球学者库

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

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:

Hogan Catherine A.¹²,Garamani Natasha¹,Lee Andrew S.¹,Tung Jack K.¹,Sahoo Malaya K.¹,Huang ChunHong¹,Stevens Bryan¹²,Zehnder James¹,Pinsky Benjamin A.¹²³^ORCID

Affiliation:

1. Department of Pathology, Stanford University School of Medicine, Stanford, California, USA

2. Clinical Virology Laboratory, Stanford Health Care, Stanford, California, USA

3. Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA

Abstract

Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope ( E ) gene.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01072-20

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