Omixon and SeqOnce Biosciences announce the launch of a new extension to the AzureSeq One-Step Universal RT-qPCR kit for the detection of the novel coronavirus SARS-CoV-2 N501Y variant. The AzureSeq One-Step Universal SARS-Co-V2 RT-qPCR N501Y assay uses a single-tube reaction targeting the N1 nucleocapsid gene, both alleles of S gene N501Y (A23063T), and includes RNaseP as a control. The assay uses common qPCR instruments with detection channels of FAM, HEX, Cy5, and ROX.

The recent surge in coronavirus cases in London, UK, Northern Ireland, Denmark, Portugal, Brazil and South Africa were linked to more infectious new variants of SARS-CoV-2. The common feature of these variants is the N501Y mutation in the spike protein. Studies from Imperial College estimate that the new variant in the UK infects 50% more people or increases the reproduction rate by 50%. Laboratories reported higher copy numbers in samples taken from people infected with the new variant. There is an observation of higher mortality rate, but it is unknown whether it is specifically linked to the new variant.

"The AzureSeq N501Y assay provides health officials, clinical labs, and hospitals the ability to quickly identify and monitor this important SARS-CoV-2 variant," said Joe Dunham, CSO of SeqOnce. "We decided to also target the N1 gene so the assay can be used in front-line detection, as well as identification of samples that have previously tested positive."

The AzureSeq-200 CE IVD kit is a one-step detection kit that can be used with or without RNA extraction for the detection of SARS-CoV-2. The benefit of AzureSeq-200 CE IVD includes reduced turn-around time of 90 minutes in direct mode. The new extension enables the monitoring of the progression of the 2 variants in and report it as a first line estimation to the authorities to take appropriate decisions.