7th December 2021

Evaluating Omicron and Other SARS-CoV-2 Variants to Ensure Test Effectiveness

SARS-CoV-2, like all viruses, evolves over time through mutations, as it spreads and replicates. Since the beginning of the COVID-19 pandemic, many variants of the SARS-CoV-2 virus, with different sets of mutations, have been observed worldwide. Most changes have little impact on the virus’ properties. However, some may cause increased transmissibility, severity of disease or the ability to evade the host immune response. Surveillance of genetic variations is therefore crucial to identify those variants which pose a higher risk to human health.

Variants may impact the performance of current diagnostic approaches. This is why Randox continuously review public genomic databases to assess whether any emerging mutations overlap with the assay design and monitor assay performance as part of post-market surveillance efforts to ensure the coronavirus assays continue to meet the highest quality standards.

In light of the emergence of the new variant of concern detected in South Africa, Omicron (B.1.1.529), Randox have analysed all publicly available sequences of the variant to predict any impact of defining mutations on assay designs.

As the COVID-19 assays from Randox Laboratories Ltd. are designed using a dual-target approach (ORf1ab, E gene) to reduce the impact of genetic variation in the SARS-CoV-2 genome, detection of SARS-CoV-2 is not predicted to be affected by the currently known variants.

Detection of SARS-CoV-2 using the Vivalytic rapid RT-PCR tests, targeting the E gene sequence are not affected by the identified mutations. Assay performance is not predicted to be impaired by the current known variants.

Randox Laboratories Ltd., in collaboration with leading technology manufacturer Bosch Healthcare Solutions, have developed a range of COVID-19 testing solutions, providing clear and concise results in a timely manner, directly at the point of care. Randox is a distributor for Vivalytic platform and cartridges.

For all enquiries regarding our COVID-19 assays performance , please contact marketing@randox.com