IEEE Open Journal of Engineering in Medicine and Biology (Jan 2021)

RADx Variant Task Force Program for Assessing the Impact of Variants on SARS-CoV-2 Molecular and Antigen Tests

  • Richard Creager,
  • John Blackwood,
  • Thomas Pribyl,
  • Leda Bassit,
  • Anuradha Rao,
  • Morgan Greenleaf,
  • Filipp Frank,
  • Wilbur Lam,
  • Eric Ortlund,
  • Raymond Schinazi,
  • Alexander Greninger,
  • Mia Cirrincione,
  • Dale Gort,
  • Emily Kennedy,
  • Adam Samuta,
  • Megan Shaw,
  • Brian Walsh,
  • Eric Lai

DOI
https://doi.org/10.1109/OJEMB.2021.3116490
Journal volume & issue
Vol. 2
pp. 286 – 290

Abstract

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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 (RADxSM) 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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