The new SARS-CoV-2 mutant (VOC 202012/01) has become the dominant variant in the United Kingdom (UK) with the first known case in the United States identified on December 29, 2020. Over sixty percent of COVID-19 infections in the UK are now attributed to the new variant. The new variant is defined by 23 mutations, 13 of which are non-synonymous point mutations. In addition, there are 4 deletions and 6 synonymous point mutations.

Viral mutations are not unexpected, this is an unusually large number of mutations in a single cluster. Mutations that enhance the virus’s capacity to spread among people provide a new variant with an advantage over the ancestral strain and enable the new variant to become dominant is its capacity to spread. Commercially available SARS-CoV-2 molecular assays often target the ORF region, as well as genes encoding for envelope protein (E), S and/or nucleoprotein (N). Therefore, the mutations in the new SARS VOC could theoretically impact the accuracy of assays that target ORF8 and S.

• Our high throughput platform (Roche cobas 6800) targets the ORF1ab region and E gene,

• Our rapid point-of-care platform similarly targets the ORF1ab region, but also detects the N gene.

The selection of ORF1ab and N targets is due to their highly conserved nature (i.e., less likely to mutate) and their unique sequence specific for SARS-CoV-2. In contrast, the use of the E gene serves as a pan-Sarbecovirus marker. It must be noted that N and E mutations do exist but have not increased in prevalence since these variants appear to be no more infectious than non-mutants. Situations may arise where only one out of two targets are detected. Detection of only one gene does not necessarily indicate the presence of a new variant and may be the result of low viral load.