SARS-CoV-2 Variants II (S gene P681R, L452R and E484Q) RTU qPCR CE/IVD

Intended Use

Vitassay qPCR SARS-CoV-2 Variants II allows the qualitative detection of RNA from genetic mutations in the S gene (P681R, L452R and E484Q) 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 (P681R, L452R and E484Q) 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 II Plate
- SARS-CoV-2 Variants II 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