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Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test.
Mostafa, Heba H; Lamson, Daryl M; Uhteg, Katharine; Geahr, Melissa; Gluck, Linda; de Cárdenas, Jessica N Brazelton; Morehead, Elizabeth; Forman, Michael; Carroll, Karen C; Hayden, Randall T; George, Kirsten St.
  • Mostafa HH; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA. Electronic address: Hmostaf2@jhmi.edu.
  • Lamson DM; Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, USA.
  • Uhteg K; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • Geahr M; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • Gluck L; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • de Cárdenas JNB; Department of Pathology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-3678, USA.
  • Morehead E; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • Forman M; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • Carroll KC; Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.
  • Hayden RT; Department of Pathology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-3678, USA. Electronic address: Randall.Hayden@STJUDE.ORG.
  • George KS; Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, USA. Electronic address: kirsten.st.george@health.ny.gov.
J Clin Virol ; 130: 104583, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-712205
ABSTRACT
The SARS-CoV-2 virus has caused millions of confirmed COVID-19 cases worldwide and hundreds of thousands of deaths in less than 6 months. Mitigation measures including social distancing were implemented to control disease spread, however, thousands of new cases continue to be diagnosed daily. To resume some suspended social activities, early diagnosis and contact tracing are essential. To meet this required diagnostic and screening capacity, high throughput diagnostic assays are needed. The NeuMoDx™ SARS-CoV-2 assay, performed on a NeuMoDx molecular system, is a rapid, fully automated, qualitative real-time RT-PCR diagnostic test with throughput of up to 288 tests in an 8 -h shift. The assay received emergency use authorization from the FDA and is used in some large testing centers in the US. This paper describes the analytical and clinical performance of the assay at three centers Johns Hopkins Hospital, St. Jude Children's Research Hospital, and the Wadsworth Center.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / High-Throughput Screening Assays Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / High-Throughput Screening Assays Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article