Multicenter evaluation of the NeuMoDxâ„¢ 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.

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.