Detection of variant SARS-CoV-2 strains on the ePlex^® RP2 Panel^*

February 9, 2021

Genetic surveillance of SARS-CoV-2 strains circulating globally has identified multiple variants containing one or more mutations that can potentially impact detection by nucleic acid based testing methods. These variants can also impact behavior of the virus, such as making a virus more or less transmissible or capable of causing more severe illness. Health organizations around the world are closely monitoring the circulation of these known variants and are also working to identify any additional variants that arise.

The ePlex Respiratory Pathogen Panel 2 (RP2 Panel) targets 2 unique regions of the N (nucleoprotein) gene. The GenMark bioinformatics team performs regular sequence analysis of available SARS-CoV-2 strains to review new mutations and to determine if these variants affect the performance of the ePlex RP2 Panel SARS-CoV-2 assays.

The table below summarizes SARS-CoV-2 variant strains identified to date and the impact, if any, on the ePlex RP2 Panel based on bioinformatic analysis.^1-7 This list will be updated as new strain information becomes available. This list is not intended to be a comprehensive list of all variants or mutations identified; it includes the most prevalent variants in circulation and mutations that are believed to be clinically significant. Based on analysis of currently available sequence information, the variants shown on the table do not include mutations that would impact the performance of the ePlex RP2 Panel SARS-CoV-2 assays and these strains will be detected as expected.

*For use under the Emergency Use Authorization (EUA) only. For in vitro diagnostic use.

1. Centers for Disease Control and Prevention.  Emerging SARS-CoV-2 Variants.  https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html (accessed January 2021)
2. European Centre for Disease Prevention and Control. January 21, 2021. Risk Related to Spread of New SARS-CoV-2 Variants of Concern in the EU/EEA- first update.
3. Zimmer, K. January 26, 221.  A guide to emerging SARS-CoV-2 variants.  The Scientist.  https://www.the-scientist.com/news-opinion/a-guide-to-emerging-sars-cov-2-variants-68387
4. Jones, A.  January 2021.  Coronavirus variant linked to COIVD-19 outbreaks in California.  The Scientist. https://www.the-scientist.com/news-opinion/coronavirus-variant-linked-to-covid-19-outbreaks-in-california-68365
5. Tu, H. et al. (2021) Distinct patterns of emergence of SARS-CoV-2 spike variants including N501Y in clinical samples in Columbus Ohio.  bioRxiv 2021.01.12.426407; doi: https://doi.org/10.1101/2021.01.12.426407
6. Zimmer, C. January 19, 2021.  New California variant may be driving virus surge there, study suggests.  New York Times.  https://www.nytimes.com/2021/01/19/health/coronavirus-variant-california.html
7. Centers for Disease Control and Prevention. SARS-CoV-2 Variants. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html (accessed February 2021)