The SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit is an isothermal assay that targets regions in the N and E genes of the SARS-CoV-2 viral genome. Primers for both target regions are present in the same reaction, so amplification of either target can generate a positive signal. The new COVID-19 variant, Omicron, contains one point mutation in a region of the E-gene that is targeted by the LAMP primers in this kit. Given the position of this mutation and the overall tolerance of LAMP to point mutations, we do not anticipate a significant impact to assay performance with the Omicron (B.1.1.529) variant.
To assess this experimentally, direct testing of IVT RNA representing both the wild-type (Wuhan) and mutant SARS-CoV-2 (Omicron) Egene templates was conducted in the presence of wild-type N gene RNA, and substantially equivalent results were observed across a 3-log range of inputs. At low input ( 50 copies/rxn), 100% detection of both samples (36/36 replicates tested) was observed.
