A novel diagnostic test to screen SARS-CoV-2 variants containing E484K and N501Y mutations

Spike protein mutations E484K and N501Y carried by SARS-CoV-2 variants have been associated with concerning changes of the virus, including resistance to neutralizing antibodies and increased transmissibility. While the concerning variants are fast spreading in various geographical areas, identification and monitoring of these variants are lagging far behind, due in large part to the slow speed and insufficient capacity of viral sequencing. In response to the unmet need for a fast and efficient screening tool, we developed a single-tube duplex molecular assay for rapid and simultaneous identification of E484K and N501Y mutations from nasopharyngeal swab (NS) samples within 2.5 h from sample preparation to report. Using this tool, we screened a total of 1135 clinical NS samples collected from COVID patients at 8 hospitals within the Hackensack Meridian Health network in New Jersey between late December 2020 and March 2021. Our data revealed dramatic increases in the frequencies of both E484K and N501Y over time, underscoring the need for continuous epidemiological monitoring.

Emerg Microbes Infect. 2021 Dec;10(1):994-997. doi: 10.1080/22221751.2021.1929504.


Other Contributors

Yanan Zhao 1 2Annie Lee 1Kaelea Composto 1Marcus H Cunningham 1Jose R Mediavilla 1Samantha Fennessey 3André Corvelo 3Kar Fai Chow 4Michael Zody 3Liang Chen 1 2Barry N Kreiswirth 1 2 5David S Perlin 1 2 5


  • 1Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA.
  • 2Hackensack Meridian School of Medicine, Nutley, NJ, USA.
  • 3New York Genome Center, New York, NY, USA.
  • 4Core Laboratory, Department of Pathology, Hackensack University Medical Center, Hackensack, NJ, USA.
  • 5Georgetown University Lombardi Comprehensive Cancer Center, Washington, DC, USA.