SARS-CoV-2 Variants (S gene E484K, K417N, K417T and N501Y) RTU qPCR CE/IVD

Intended Use

Vitassay qPCR SARS-CoV-2 Variants allows the qualitative detection of RNA from genetic mutations in the S gene (E484K, K417N, K417T and N501Y) by real-time RT-PCR in positive SARS-CoV-2 nasopharyngeal samples. The test is intended for use in the monitoring of the prevalence of genetic mutations in the S gene (E484K, K417N, K417T, and N501Y) and to support control measures.

Vitassay qPCR Kits contains in each well enzymes, buffer, primer and probes as well as an internal control in a lyophilized format.
The kits include a positive and a negative control.

Identification of pathogen DNA or RNA occurs by the use of target specific primers ans fluorecent labeled hydrolysis probes which hybridize conserved regions in the genomes of the different pathogens.

Kit Content:
- SARS-CoV-2 Variants Plate
- SARS-CoV-2 Variants Positive Control: 1 vial
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1,8 mL
- Negative control (yellow):1 vial x 1 mL
- Optical caps: 12x8 cap strip

Kit Format: qualitative