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

REF 176A50

Description

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.

 

Ordering information

Product

Reference

GTIN

UltraGene Assay SARS-CoV-2 VOC Screening and Determination V1 (CE– 50 tests)

176A50

5407007960477

UltraGene Assay SARS-CoV-2 VOC Screening and Determination V1 (CE – 1000 tests)

176A1000

5407007960460

Downloads

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Request of Documentation (IFU, MSDS, CoA, ...)

     

    For “In-Vitro Diagnostic use (IVD)” where indicated : CE marking only valid for EEA and territories recognizing it. Otherwise “For Research Use Only” (RUO): not for use in diagnostic procedures, no claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.