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Multicenter Study
. 2020 Sep:130:104583.
doi: 10.1016/j.jcv.2020.104583. Epub 2020 Aug 7.

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

Heba H Mostafa  1 , Daryl M Lamson  2 , Katharine Uhteg  3 , Melissa Geahr  3 , Linda Gluck  3 , Jessica N Brazelton de Cárdenas  4 , Elizabeth Morehead  3 , Michael Forman  3 , Karen C Carroll  3 , Randall T Hayden  5 , Kirsten St George  6
Affiliations
Multicenter Study

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

Heba H Mostafa et al. J Clin Virol. 2020 Sep.

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.

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Conflict of interest statement

KCC: Scientific advisory board for Pattern Diagnostics, Inc. and Scanogen, Inc., Research funds paid to the institution from BD Diagnostics, LBT Innovations, GenePOC, Inc., MeMed, Inc.

KSG: Research support from ThermoFisher and has a royalty generating collaborative agreement with Zeptometrix.

RTH: Advisory boards for Roche Molecular and Quidel Corporation.

HHM: Research funds from DiaSorin Molecular and Bio-Rad Laboratories.

Figures

Fig. 1
Fig. 1
Effect of NeuMoDx on COVID-19 testing workflow and Turn-around time at Johns Hopkins Hospital. Turn-around time was calculated from specimen collection to reporting of results.
See this image and copyright information in PMC

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