UltraGene Assay SARS-CoV-2 VOC Screening and Determination V1 (CE-IVD)

Intended use
UltraGene Assay SARS-CoV-2 VOC Screening & Determination V1.X is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test (nucleic acid technique (NAT)) intended for the qualitative detection of SARS-CoV-2 mutations L452R, K417N or K417T, E484A or E484K or E484Q, and the deletion 69-70 on the Spike (S) gene. The test is targeting the S and N regions of SARS-CoV-2 patients’ extracted RNA and already diagnosed PCR positive to SARS-CoV-2.

The detected mutations and the deletion 69-70 are indicative of the possible presence of a SARS-CoV-2 variant of concern which is associated with a higher transmissibility rate which impacts health systems with further hospitalizations and deaths.

UltraGene Assay SARS-CoV-2 VOC Screening & Determination V1.X is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR.