Article
Design and Implementation of Improved SARS-CoV-2 Diagnostic Assays To Mitigate the Impact of Genomic Mutations on Target Failure: the Xpert Xpress SARS-CoV-2 Experience.
Microbiology spectrum - 21 Dec 2022
Burns Bethany L, Moody Domonique, Tu Zheng Jin, Nakitandwe Joy, Brock Jay E, Bosler David, Mitchell Stephanie L, Loeffelholz Michael J, Rhoads Daniel D
Abstract excerpt
In 2020, the U.S. Food and Drug Administration (FDA) enabled manufacturers to request emergency use authorization (EUA) to facilitate the rapid authorization of in vitro diagnostic (IVD) platforms for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Uncommon SARS-CoV-2 point mutations could cause nucleocapsid (N) gene target failure (NGTF) when using first-generation Xpert Xpress...
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