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Special Issue Virology

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

Catherine A. Hogan, Natasha Garamani, Andrew S. Lee, Jack K. Tung, Malaya K. Sahoo, ChunHong Huang, Bryan Stevens, James Zehnder, Benjamin A. Pinsky
Alexander J. McAdam, Editor
Catherine A. Hogan
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
bClinical Virology Laboratory, Stanford Health Care, Stanford, California, USA
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Natasha Garamani
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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Andrew S. Lee
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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Jack K. Tung
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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Malaya K. Sahoo
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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ChunHong Huang
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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Bryan Stevens
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
bClinical Virology Laboratory, Stanford Health Care, Stanford, California, USA
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James Zehnder
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
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Benjamin A. Pinsky
aDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA
bClinical Virology Laboratory, Stanford Health Care, Stanford, California, USA
cDivision of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA
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Alexander J. McAdam
Boston Children's Hospital
Roles: Editor
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DOI: 10.1128/JCM.01072-20
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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. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen’s kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula.

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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens
Catherine A. Hogan, Natasha Garamani, Andrew S. Lee, Jack K. Tung, Malaya K. Sahoo, ChunHong Huang, Bryan Stevens, James Zehnder, Benjamin A. Pinsky
Journal of Clinical Microbiology Jul 2020, 58 (8) e01072-20; DOI: 10.1128/JCM.01072-20

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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens
Catherine A. Hogan, Natasha Garamani, Andrew S. Lee, Jack K. Tung, Malaya K. Sahoo, ChunHong Huang, Bryan Stevens, James Zehnder, Benjamin A. Pinsky
Journal of Clinical Microbiology Jul 2020, 58 (8) e01072-20; DOI: 10.1128/JCM.01072-20
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KEYWORDS

COVID-19
laboratory-developed test
Mesa Accula
point-of-care test
SARS-CoV-2

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