IEEE Open Journal of Engineering in Medicine and Biology（2021）
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摘要
Goal:
Monitoring the genetic diversity and emerging mutations of SARS-CoV-2 is crucial for understanding the evolution of the virus and assuring the performance of diagnostic tests, vaccines, and therapies against COVID-19. SARS-CoV-2 is still adapting to humans and, as illustrated by B.1.1.7 (Alpha) and B.1.617.2 (Delta), lineage dynamics are fluid, and strain prevalence may change radically in a matter of months. The National Institutes of Health's Rapid Acceleration of Diagnostics (RADx
SM
) initiative created a Variant Task Force to assess the impact of emerging SARS-CoV-2 variants on
in vitro
diagnostic testing. Working in tandem with clinical laboratories, the FDA, and the CDC, the Variant Task Force uses both
in silico
modeling and
in vitro
testing to determine the effect of SARS-CoV-2 mutations on diagnostic molecular and antigen tests. Here, we offer an overview of the approach and activities of the RADx Variant Task Force to ensure test performance against emerging SARS-CoV-2 lineages.
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关键词
COVID-19,in vitro diagnostics,mutations,SARS-CoV-2,variants of concern
