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

ABSTRACT 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 SA...

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Principais autores:	Bethany L. Burns, Domonique Moody, Zheng Jin Tu, Joy Nakitandwe, Jay E. Brock, David Bosler, Stephanie L. Mitchell, Michael J. Loeffelholz, Daniel D. Rhoads
Formato:	Artigo
Idioma:	Inglês
Publicado em:	American Society for Microbiology 2022-12-01
coleção:	Microbiology Spectrum
Assuntos:	Cepheid FDA emergency use authorization gene mutations NGTF SARS-CoV-2 target failures
Acesso em linha:	https://journals.asm.org/doi/10.1128/spectrum.01355-22
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