Update Regarding Variant Strains of SARS-CoV-2
United States public health agencies regularly monitor SARS-CoV-2 genetic lineages through epidemiological investigations, laboratory studies and genetic sequence-based surveillance. The US government SARS-CoV-2 Interagency Group (SIG) has designated the following classes of SARS-CoV-2 variants of public health interest: Variants of High Consequence (VOHC), Variants of Concern (VOC), Variants of Interest (VOI), and Variants Being Monitored (VBM).*
Rheonix has conducted analysis of the potential impact of all classes of variants being monitored and has determined that they should not impact performance of the Rheonix COVID-19™ MDx assay.
Rheonix continually evaluates publicly available SARS-CoV-2 genetic sequences to identify the potential impact of variants on our assay performance. Our assessments indicate that all characterized SARS-CoV-2 variants currently being monitored should be detected by the Rheonix COVID-19 MDx assay, as summarized in the table below. We will continue to monitor the available sequences weekly to identify any potentially concerning mutations as they emerge.
| WHO Label | PANGO Lineage | CDC Variant Classification* | Impact to Rheonix COVID-19™ MDx Assay |
| Delta | B.1.617.2 and AY lineages | VOC | No impact |
| Omicron | B.1.1.529, including BA lineages | VOC | No impact |
| Alpha | B.1.1.7 and Q lineages | VBM | No impact |
| Beta | B.1.351 and descendent lineages | VBM | No impact |
| Gamma | P.1 and descendent lineages | VBM | No impact |
| Epsilon | B.1.427/B.1.429 | VBM | No impact |
| Eta | B.1.525 | VBM | No impact |
| Iota | B.1.526 | VBM | No impact |
| Kappa | B.1.617.1 | VBM | No impact |
| N/A | B.1.617.3 | VBM | No impact |
| Mu | B.1.621, B.1.621.1 | VBM | No impact |
| Zeta | P.2 | VBM | No impact |
*Source: SARS-CoV-2 Variants of Concern | CDC
