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

September 3, 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 in GISAID database to monitor for mutations in the N gene regions targeted by the ePlex RP2 Panel SARS-CoV-2 assays. Mutations in other regions of the genome, such as the spike protein or envelope protein, have no impact on the performance of the SARS-CoV-2 assays on the ePlex RP2 Panel.

The bioinformatic assessment includes expected performance of both the N1 and N2 SARS-CoV-2 assays for any mutation located within the gene regions targeted by the two assays.

The table below summarizes known SARS-CoV-2 variant strains and the impact, if any, on the ePlex RP2 Panel based on bioinformatic analysis.

• This list will be updated as new 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 believed to be clinically significant.
• For the most up to date information on specific mutations identified in each strain and prevalence, please refer to your regional health authorities.

Click here to learn more about Omicron variant detection on the ePlex RP2 Panel.

*The ePlex RP2 Panel is for use under Emergency Use Authorization (EUA) only. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2 and multiple respiratory viral and bacterial organisms; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.