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

J Clin Virol. 2020 Sep:130:104583. doi: 10.1016/j.jcv.2020.104583. Epub 2020 Aug 7.

Affiliations

¹ 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.
² Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, USA.
³ 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.
⁴ Department of Pathology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-3678, USA.
⁵ Department of Pathology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-3678, USA. Electronic address: Randall.Hayden@STJUDE.ORG.
⁶ Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, USA. Electronic address: kirsten.st.george@health.ny.gov.

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.

Keywords: COVID-19; NeuMoDx; SARS-CoV-2.

Publication types

Evaluation Study
Multicenter Study

MeSH terms

Automation, Laboratory
Betacoronavirus
COVID-19
COVID-19 Testing
COVID-19 Vaccines
Clinical Laboratory Techniques / methods*
Coronavirus Infections / diagnosis*
Coronavirus Infections / virology
High-Throughput Screening Assays / methods*
Humans
Pandemics
Pneumonia, Viral / diagnosis*
Pneumonia, Viral / virology
SARS-CoV-2
Sensitivity and Specificity
Specimen Handling