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

November 10, 2022

As genetic surveillance of SARS-CoV-2 strains circulating globally continues to identify new variants and mutations that can potentially impact detection by nucleic acid-based testing methods, GenMark continues to monitor the evolution of SARS-CoV-2 variants and remains committed to providing laboratories with high-quality testing solutions that aid in the diagnosis of patients with SARS-CoV-2. In silico analyses have been continuously performed since the onset of the pandemic and continue to conclude that the ePlex Respiratory Pathogen 2 Panel (RP2 Panel) will detect all analyzed SARS-CoV-2 sequences in NCBI and GISAID databases.

The ePlex RP2 Panel targets 2 unique regions of the N (nucleoprotein) gene. 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 these assays.

The table below summarizes 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. Strains no longer circulating and strains no longer being monitored have been removed from the table.
• For the most up to date information on variants, please refer to your regional health authorities.

*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.