Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test

Heba H. Mostafa; Daryl M. Lamson; Katharine Uhteg; Melissa Geahr; Linda Gluck; Jessica N.Brazelton de Cárdenas; Elizabeth Morehead; Michael Forman; Karen C. Carroll; Randall T. Hayden; Kirsten St George

doi:10.1016/j.jcv.2020.104583

Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test

Heba H. Mostafa, Daryl M. Lamson, Katharine Uhteg, Melissa Geahr, Linda Gluck, Jessica N.Brazelton de Cárdenas, Elizabeth Morehead, Michael Forman, Karen C. Carroll, Randall T. Hayden, Kirsten St George

School of Medicine

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

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.

Original language	English (US)
Article number	104583
Journal	Journal of Clinical Virology
Volume	130
DOIs	https://doi.org/10.1016/j.jcv.2020.104583
State	Published - Sep 2020

Keywords

COVID-19
NeuMoDx
SARS-CoV-2

ASJC Scopus subject areas

Virology
Infectious Diseases

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10.1016/j.jcv.2020.104583

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title = "Multicenter evaluation of the NeuMoDx{\texttrademark} SARS-CoV-2 Test",

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{\texttrademark} 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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author = "Mostafa, {Heba H.} and Lamson, {Daryl M.} and Katharine Uhteg and Melissa Geahr and Linda Gluck and {de C{\'a}rdenas}, {Jessica N.Brazelton} and Elizabeth Morehead and Michael Forman and Carroll, {Karen C.} and Hayden, {Randall T.} and George, {Kirsten St}",

note = "Funding Information: We thank the entire Medical Microbiology division for their assistance with this study. We also thank BioRad Laboratories for their collaboration. Publisher Copyright: {\textcopyright} 2020 The Author(s)",

year = "2020",

month = sep,

doi = "10.1016/j.jcv.2020.104583",

language = "English (US)",

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AU - Gluck, Linda

AU - de Cárdenas, Jessica N.Brazelton

AU - Morehead, Elizabeth

AU - Forman, Michael

AU - Carroll, Karen C.

AU - Hayden, Randall T.

AU - George, Kirsten St

N1 - Funding Information: We thank the entire Medical Microbiology division for their assistance with this study. We also thank BioRad Laboratories for their collaboration. Publisher Copyright: © 2020 The Author(s)

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N2 - 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.

AB - 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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Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test

Abstract

Keywords

ASJC Scopus subject areas

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