The United Kingdom has reported a new variant, termed VUI 202012/01. Defined by multiple mutations in the viral spike protein (deletion 69-70, deletion 144-145, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H), with N501Y and Y145del being possible sites directly contributing to its increased infectious efficiency. While it is unclear if this variant remains detectable by assays currently using the Spike protein (S gene) as an rRT-PCR target, the available data suggest that assays using other targets will detect this new strain.
The MicroGenDX COVID-19 KEY uses two regions of the Nucleocapsid (N gene) which, at present, appear to be conserved in the new strain meaning the COVID-19 KEY assay will reliably detect this variant under investigation. The extent of circulation of the new strain has not yet been determined and further mutations in the viral genome remain a possibility. MicroGenDX will continue to monitor emerging strains and adapt the COVID-19 KEY as necessary. A threat assessment brief from the European Centre for Disease Prevention and Control has been
included as an attachment with this notice.