VIASURE SARS-CoV-2 & UK Variant (S UK, S and N genes) Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 and the HV 69/70 deletion of the S gene for SARS-CoV-2 associated to the SARS-CoV-2 VOC202012/01 (lineage B.1.1.7) variant and other variants in nasopharyngeal swabs from individuals suspected of SARS-CoV-2 infection disease (COVID-19)by their healthcare professional (HCP).

RNA is extracted from respiratory specimens. Complementary DNA (cDNA) is synthetised and amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2 and HV 69/70 deletion.

On December 14, 2020, the United Kingdom declared an increase in the incidence of SARSCoV-2 in some regions associated with a new variant of the virus with a supposed greater transmission capacity. This variant, called VOC202012/01 (B.1.1.7) presented 23 different mutations: 13 non-synonymous, including a series of mutations in the spike protein (S), 4 deletions and 6 synonymous. By the end of December, this variant had been detected in 31 countries and territories in 5 of the 6 WHO regions. One of the mutations is the deletion at positions 69-70 in the spike protein.

Detection of the HV 69/70 deletion is of great importance since it has been related to immune leakage in immunosuppressed patients and to increased viral infectivity. Another cause for concern in relation to the HV 69/70 deletion is that it affects the sensitivity of virus detection using molecular techniques (RT-PCR) that detects the S gene.