Detection of Omicron variant on the ePlex® RP2 Panel*
November 29, 2021
A new SARS-CoV-2 variant first reported in South Africa and Botswana, B.1.1.529, has now been designated by the WHO as a Variant of Concern (VOC) and assigned the Greek name Omicron.1 In the US, this variant is being closely monitored though no cases have been reported yet. Globally, cases have been reported in Australia, Britain, Belgium, Botswana, Denmark, Germany, France, Italy, Hong Kong, Israel, Netherlands, Czech Republic, Austria, Canada, and South Africa; this list is quickly expanding as additional cases are identified.2 The number of mutations in this variant is causing concern, and over 30 mutations have been reported in the spike protein region alone.3 A virologist in the UK noted this is the most heavily mutated version of the virus yet identified.4
The GenMark ePlex Respiratory Pathogen Panel 2 (RP2 Panel) targets 2 unique regions of the N gene. Preliminary analysis of the Omicron variant based on 91 sequences available in GISAID (as of November 26, 2021) indicates that there are no detrimental mutations in the N gene regions targeted by the ePlex RP2 Panel SARS-CoV-2 assays and there is predicted inclusivity of 100% for this variant.
Click here to learn more about other SARS-CoV-2 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.