E484K mutation (RTPCR010)

E484K mutation (RTPCR010)

The RTPCR010 reference does not include the Spike E484K mutation for detecting SARS-CoV-2 variants, as it does not provide any additional discrimination of variants when HV69/70 and N501Y are already used. Additionally, including it would limit the assay to a two-step process. This test has been designed to be compatible with four-channel thermocyclers and to be performed in a single step. Most commercial kits rely on two-step protocols: first, detecting SARS-CoV-2 in the sample, and then performing a variant identification test, which increases costs and workload.

RTPCR010 takes a different approach:

- It includes an internal control (human RNAseP) and generic SARS-CoV-2 targets (N gene), which can be used for both diagnosis and variant identification in a single step.

- The assay detects alterations in the wild-type residue, rather than a specific mutation, which allows the identification of new mutations, such as K417N/T or E484Q (in addition to E484K), that might not be detected using a mutation-specific detection strategy.