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FEN001 - Clarigene® STAYS AHEAD OF THE CURVE WITH RIGOROUS ONGOING VIRAL SURVEILLANCE.

INTRODUCTION
For manufacturers of viral diagnostic assays, close monitoring for the emergence of new strains is essential. This is especially true currently for assays that detect SARS-CoV-2, as the ability to reliably diagnose cases is an important pillar in managing the ongoing pandemic. A viral strain that disrupts a primer or probe site for PCR-based assays could at worst lead to a false negative result.

A virus that encodes its genome in RNA, such as SARS-CoV-2, HIV and influenza, tends to mutate quickly once inside a host primarily because enzymes involved in RNA replication are error prone. However, data suggests that coronaviruses mutate at a slower rate than most other RNA viruses due to an inbuilt proofreading mechanism. On average a SARS-CoV-2 virus mutates at about half the rate of influenza, or at one-quarter of that seen in HIV.


Many of the mutations seen in SARS-CoV-2 have no impact on the ability of the virus to cause or spread disease. Mutations in the ‘spike’ protein (S) are of particular relevance because of key role of this viral portion in antibody recognition. The European Centre for Disease Prevention (ECDC) has established a system for classifying emerging variants, from those ‘under monitoring’ through to those ‘of concern’. For so called ‘Variants of Concern’ (VOC), ‘clear evidence is available indicating a significant impact on transmissibility, severity and/or immunity that is likely to have an impact on the epidemiological situation in the EU/EEA’ (ECDC). In November 2020, the ECDC issued a threat assessment brief regarding a SARS-CoV-2 variant with multiple S protein mutations that was in high circulation in the UK (B.1.1.7 lineage). Analysis at that time suggested this strain was exhibiting increased transmissibility of up to 70%. Since then there have been further lineages for concern detected with multiple spike mutations, such as the 2OH/501Y.V2 variant first identified in South Africa. These developments suggest that, in line with previous experience of viral respiratory illness outbreaks, monitoring of the S gene is of paramount importance.


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