Since the beginning of the COVID-19 pandemic, Sentinel Diagnostics has been working constantly to provide high-quality diagnostic tests, based on patented STAT-NAT® technology, for the detection of SARS-CoV-2 virus.
We are constantly monitoring the effectiveness of our NAT tests for the detection of COVID-19 by verifying that variant-defining mutant loci do not fall within primers/probes annealing regions. We confirm that our kits STAT-NAT®COVID-19 MULTI (REF. #1N036, N041), STAT-NAT®SARS-CoV-2 (REF. #1N044, 1N045) are not affected by the newly appeared B.1.1.529, or Omicron, variant. From this standpoint, our STAT-NAT® kits should maintain their analytical and clinical performances and fully preserve the capability to detect the virus.
The Omicron variant (B.1.1.529) recently characterized in South Africa has been classified as “Variant of Concern” (VOC) by World Health Organization on Nov 26th, 2021. It belongs to the Pango lineage B.1.1.529, Nextstrain clade 21K, and it has 30 amino acids changes, three small deletions and one small insertion in the spike protein alone. There are several uncertainties around the Omicron variant in terms of transmissibility, severity, and potential immune resistance that require further investigation. Though, mathematical modelling conducted by ECDC, indicates that such variant could cause over half of all SARS-CoV-2 infections in the EU/EEA within the next few months, taking advantage over Delta variant. This raises the need to use RT-PCR assay that can detect the infection caused by Omicron, as well as the other VOC variants know so far (Alpha B.1.1.7; Beta B.1.351; Gamma P1; Delta B.1.617.2).
Our STAT-NAT® kits are designed to ensure reliable results regardless of the presence of potential mutations. Indeed, all our kits detect multiple highly conservative genes and exclude the detection of S-gene, which is more prone to mutations. In detail, primers included in STAT-NAT®COVID-19 MULTI (REF. #1N036, N041) master mixes detect RdRP and Orf1b genes and primers included in STAT-NAT®SARS-CoV-2 #1N044, 1N045) detect RdRP, N- and E-genes of SARS-CoV-2.