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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.
Hogan, Catherine A; Garamani, Natasha; Lee, Andrew S; Tung, Jack K; Sahoo, Malaya K; Huang, ChunHong; Stevens, Bryan; Zehnder, James; Pinsky, Benjamin A.
  • Hogan CA; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Garamani N; Clinical Virology Laboratory, Stanford Health Care, Stanford, California, USA.
  • Lee AS; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Tung JK; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Sahoo MK; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Huang C; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Stevens B; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Zehnder J; Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.
  • Pinsky BA; Clinical Virology Laboratory, Stanford Health Care, Stanford, California, USA.
J Clin Microbiol ; 58(8)2020 Jul 23.
Article in English | MEDLINE | ID: covidwho-999209
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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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Molecular Diagnostic Techniques / Point-of-Care Testing / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: JCM.01072-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Molecular Diagnostic Techniques / Point-of-Care Testing / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: JCM.01072-20