MicroGenDX COVID-19KEY will reliably detect the UK (B.1.1.7), South African (B.1.351), and Brazilian (B.1.1.28) variants.
The UK variant contains 17 mutations, most of which fall in within the Spike protein gene sequence. The N501Y mutation has been reported to bind the virus more tightly to the ACE2 cellular receptor which the virus uses to gain entry into host cells. Further research is required to determine if the variant’s enhanced contagiousness is due to N501Y alone or if other factors are involved.
The South African variant emerged concurrently with the UK variant and also contains the N501Y mutation among other mutations suggesting the two variants arose independently. Research currently under peer-review suggests that currently approved vaccines may not effectively neutralize this variant.
Two Brazilian variants both descended from an ancestor variant emerged in January 2021. They share the N501Y and other mutations with other variants but also appear to have emerged independently. The P.1 is currently more concerning to researchers and epidemiologists than the P.2 variant because P.1 has accumulated more mutations, however both may be capable of immune evasion in vaccinated individuals.
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 FDA has released an alert report citing the MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and the Linea COVID-19 Assay Kit authorized assays may be impacted (non-significantly) by genetic variants.
The MicroGenDX COVID-19 KEY, authorized for emergency use by the FDA, uses two regions of the Nucleocapsid (N gene) which, at present, appear to be conserved in the new variants meaning the COVID-19 KEY assay will reliably detect these variants. The extent of circulation of these variants 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.
COVID-19 Vaccine FAQ
Large-scale clinical studies have found that COVID-19 vaccines reduced the risk of getting COVID-19 in vaccinated people by up to 95% compared to people who did not receive the vaccine. However, the vaccines are not 100% effective in preventing infection. This means a small percentage of fully vaccinated people can be expected to still get COVID-19. These are identified as breakthrough cases. -Washington State Dept. of Health