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

•SARS-CoV-2 molecular assays are the current gold standard for diagnosis and large scale screening.•Performance of the highly automated high throughput NeuMoDx assay for SARS-CoV-2 was evaluated.•Data collected from three centers: Johns Hopkins Hospital, St. Jude Children’s Research Hospital, and th...

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Published in:Journal of clinical virology 2020-09, Vol.130, p.104583-104583, Article 104583
Main Authors: 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
Format: Article
Language:English
Subjects:
Automation, Laboratory
Betacoronavirus
Clinical Laboratory Techniques - methods
Coronavirus Infections - diagnosis
Coronavirus Infections - virology
COVID-19
COVID-19 Testing
COVID-19 Vaccines
High-Throughput Screening Assays - methods
Humans
NeuMoDx
Pandemics
Pneumonia, Viral - diagnosis
Pneumonia, Viral - virology
SARS-CoV-2
Sensitivity and Specificity
Specimen Handling
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Summary:•SARS-CoV-2 molecular assays are the current gold standard for diagnosis and large scale screening.•Performance of the highly automated high throughput NeuMoDx assay for SARS-CoV-2 was evaluated.•Data collected from three centers: Johns Hopkins Hospital, St. Jude Children’s Research Hospital, and the Wadsworth Center. 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.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2020.104583